BEUDAMED
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    The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105 03.305.500 03.305.500S Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code MQN·October 17, 2014

    TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code MQN·May 23, 2016

    TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code MQN·May 23, 2016

    TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code MQN·May 23, 2016

    TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code MQN·May 23, 2016

    TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code MQN·May 23, 2016

    Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code MQN·June 12, 2013

    DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)

    FDA Recall
    Terminated ·Synthes, Inc.·Product code MQN·April 16, 2014

    TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code MQN·May 23, 2016

    Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM IM NAIL 10MM DIA 225230010 M/DN FEM IM NAIL 10MM DIA 225232010 M/DN FEM IM NAIL 10MM DIA 225234010 M/DN FEM IM NAIL 10MM DIA 225236010 M/DN FEM IM NAIL 10MM DIA 225238010 M/DN FEM IM NAIL 10MM DIA 225240010 M/DN FEM IM NAIL 10MM DIA 225242010 M/DN FEM IM NAIL 10MM DIA 225244010 M/DN FEM IM NAIL 10MM DIA 225246010 M/DN FEM IM NAIL 10MM DIA 225228011 M/DN FEM IM NAIL 11MM DIA 225230011 M/DN FEM IM NAIL 11MM DIA 225232011 M/DN FEM IM NAIL 11MM DIA 225234011 M/DN FEM IM NAIL 11MM DIA 225236011 M/DN FEM IM NAIL 11MM DIA 225238011 M/DN FEM IM NAIL 11MM DIA 225240011 M/DN FEM IM NAIL 11MM DIA 225242011 M/DN FEM IM NAIL 11MM DIA 225244011 M/DN FEM IM NAIL 11MM DIA 225246011 M/DN FEM IM NAIL 11MM DIA 225224012 M/DN FEM IM NAIL 12MM DIA 225232012 M/DN FEM IM NAIL 12MM DIA 225234012 M/DN FEM IM NAIL 12MM DIA 225236012 M/DN FEM IM NAIL 12MM DIA 225238012 M/DN FEM IM NAIL 12MM DIA 225240012 M/DN FEM IM NAIL 12MM DIA 225242012 M/DN FEM IM NAIL 12MM DIA 225244012 M/DN FEM IM NAIL 12MM DIA 225246012 M/DN FEM IM NAIL 12MM DIA 225228013 M/DN FEM IM NAIL 13MM DIA 225230013 M/DN FEM IM NAIL 13MM DIA 225232013 M/DN FEM IM NAIL 13MM DIA 225234013 M/DN FEM IM NAIL 13MM DIA 225236013 M/DN FEM IM NAIL 13MM DIA 225238013 M/DN FEM IM NAIL 13MM DIA 225240013 M/DN FEM IM NAIL 13MM DIA 225242013 M/DN FEM IM NAIL 13MM DIA 225244013 M/DN FEM IM NAIL 13MM DIA 225246013 M/DN FEM IM NAIL 13MM DIA 225236014 M/DN FEM IM NAIL 14MM DIA 225238014 M/DN FEM IM NAIL 14MM DIA 225240014 M/DN FEM IM NAIL 14MM DIA 225242014 M/DN FEM IM NAIL 14MM DIA 225244014 M/DN FEM IM NAIL 14MM DIA 225246014 M/DN FEM IM NAIL 14MM DIA 225234015 M/DN FEM IM NAIL 15MM DIA 225240015 M/DN FEM IM NAIL 15MM DIA 225242015 M/DN FEM IM NAIL 15MM DIA 225244015 M/DN FEM IM NAIL 15MM DIA 225242016 M/DN FEM IM NAIL 16MM DIA 225230008 M/DN FEM IM NAIL 8MM DIA 225232008 M/DN FEM IM NAIL 8MM DIA 225234008 M/DN FEM IM NAIL 8MM DIA 225238008 M/DN FEM IM NAIL 8MM DIA 225228009 M/DN FEM IM NAIL 9MM DIA 225230009 M/DN FEM IM NAIL 9MM DIA 225232009 M/DN FEM IM NAIL 9MM DIA 225234009 M/DN FEM IM NAIL 9MM DIA 225236009 M/DN FEM IM NAIL 9MM DIA 225238009 M/DN FEM IM NAIL 9MM DIA 225240009 M/DN FEM IM NAIL 9MM DIA 225242009 M/DN FEM IM NAIL 9MM DIA 225244009 M/DN FEM IM NAIL 9MM DIA 225418010 M/DN HUMERAL I/M NAIL 10M 225419510 M/DN HUMERAL I/M NAIL 10M 225421010 M/DN HUMERAL I/M NAIL 10M 225422510 M/DN HUMERAL I/M NAIL 10M 225424010 M/DN HUMERAL I/M NAIL 10M 225425510 M/DN HUMERAL I/M NAIL 10M 225427010 M/DN HUMERAL I/M NAIL 10M 225428510 M/DN HUMERAL I/M NAIL 10M 225430010 M/DN HUMERAL I/M NAIL 10M 225419511 M/DN HUMERAL I/M NAIL 11M 225421011 M/DN HUMERAL I/M NAIL 11M 225422511 M/DN HUMERAL I/M NAIL 11M 225424011 M/DN HUMERAL I/M NAIL 11M 225425511 M/DN HUMERAL I/M NAIL 11M 225427011 M/DN HUMERAL I/M NAIL 11M 225421012 M/DN HUMERAL I/M NAIL 12M 225422512 M/DN HUMERAL I/M NAIL 12M 225424012 M/DN HUMERAL I/M NAIL 12M 225425512 M/DN HUMERAL I/M NAIL 12M 225427012 M/DN HUMERAL I/M NAIL 12M 225428512 M/DN HUMERAL I/M NAIL 12M 225430012 M/DN HUMERAL I/M NAIL 12M 225418013 M/DN HUMERAL I/M NAIL 13M 225424013 M/DN HUMERAL I/M NAIL 13M 225427013 M/DN HUMERAL I/M NAIL 13M 225418006 M/DN HUMERAL I/M NAIL 6MM 225419506 M/DN HUMERAL I/M NAIL 6MM 225421006 M/DN HUMERAL I/M NAIL 6MM 225424006 M/DN HUMERAL I/M NAIL 6MM 225427006 M/DN HUMERAL I/M NAIL 6MM 225428506 M/DN HUMERAL I/M NAIL 6MM 225430006 M/DN HUMERAL I/M NAIL 6MM 225418007 M/DN HUMERAL I/M NAIL 7MM 225419507 M/DN HUMERAL I/M NAIL 7MM 225421007 M/DN HUMERAL I/M NAIL 7MM 225422507 M/DN HUMERAL I/M NAIL 7MM 225424007 M/DN HUMERAL I/M NAIL 7MM 225425507 M/DN HUMERAL I/M NAIL 7MM 225427007 M/DN HUMERAL I/M NAIL 7MM 225428507 M/DN HUMERAL I/M NAIL 7MM 225430007 M/DN HUMERAL I/M NAIL 7MM 225418008 M/DN HUMERAL I/M NAIL 8MM 225

    FDA Recall
    Terminated ·Product code HSB·January 11, 2016

    Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F IM NAIL 10MM DIA 224001020 M/DN R-F IM NAIL 10MM DIA 224001022 M/DN R-F IM NAIL 10MM DIA 224001024 M/DN R-F IM NAIL 10MM DIA 224001026 M/DN R-F IM NAIL 10MM DIA 224001028 M/DN R-F IM NAIL 10MM DIA 224001030 M/DN R-F IM NAIL 10MM DIA 224001032 M/DN R-F IM NAIL 10MM DIA 224001034 M/DN R-F IM NAIL 10MM DIA 224001036 M/DN R-F IM NAIL 10MM DIA 224001038 M/DN R-F IM NAIL 10MM DIA 224001040 M/DN R-F IM NAIL 10MM DIA 224001042 M/DN R-F IM NAIL 10MM DIA 224001114 M/DN R-F IM NAIL 11MM DIA 224001116 M/DN R-F IM NAIL 11MM DIA 224001118 M/DN R-F IM NAIL 11MM DIA 224001120 M/DN R-F IM NAIL 11MM DIA 224001122 M/DN R-F IM NAIL 11MM DIA 224001124 M/DN R-F IM NAIL 11MM DIA 224001126 M/DN R-F IM NAIL 11MM DIA 224001128 M/DN R-F IM NAIL 11MM DIA 224001130 M/DN R-F IM NAIL 11MM DIA 224001132 M/DN R-F IM NAIL 11MM DIA 224001134 M/DN R-F IM NAIL 11MM DIA 224001136 M/DN R-F IM NAIL 11MM DIA 224001138 M/DN R-F IM NAIL 11MM DIA 224001140 M/DN R-F IM NAIL 11MM DIA 224001142 M/DN R-F IM NAIL 11MM DIA 224001144 M/DN R-F IM NAIL 11MM DIA 224001146 M/DN R-F IM NAIL 11MM DIA 224001218 M/DN R-F IM NAIL 12MM DIA 224001220 M/DN R-F IM NAIL 12MM DIA 224001224 M/DN R-F IM NAIL 12MM DIA 224001226 M/DN R-F IM NAIL 12MM DIA 224001228 M/DN R-F IM NAIL 12MM DIA 224001230 M/DN R-F IM NAIL 12MM DIA 224001232 M/DN R-F IM NAIL 12MM DIA 224001234 M/DN R-F IM NAIL 12MM DIA 224001236 M/DN R-F IM NAIL 12MM DIA 224001238 M/DN R-F IM NAIL 12MM DIA 224001240 M/DN R-F IM NAIL 12MM DIA 224001242 M/DN R-F IM NAIL 12MM DIA 224001244 M/DN R-F IM NAIL 12MM DIA 224001248 M/DN R-F IM NAIL 12MM DIA 224001318 M/DN R-F IM NAIL 13MM DIA 224001324 M/DN R-F IM NAIL 13MM DIA 224001326 M/DN R-F IM NAIL 13MM DIA 224001328 M/DN R-F IM NAIL 13MM DIA 224001330 M/DN R-F IM NAIL 13MM DIA 224001332 M/DN R-F IM NAIL 13MM DIA 224001334 M/DN R-F IM NAIL 13MM DIA 224001336 M/DN R-F IM NAIL 13MM DIA 224001338 M/DN R-F IM NAIL 13MM DIA 224001340 M/DN R-F IM NAIL 13MM DIA 224001344 M/DN R-F IM NAIL 13MM DIA 224001346 M/DN R-F IM NAIL 13MM DIA 224001348 M/DN R-F IM NAIL 13MM DIA 224001422 M/DN R-F IM NAIL 14MM DIA 224001436 M/DN R-F IM NAIL 14MM DIA 224001438 M/DN R-F IM NAIL 14MM DIA 224001440 M/DN R-F IM NAIL 14MM DIA 224001442 M/DN R-F IM NAIL 14MM DIA 224001444 M/DN R-F IM NAIL 14MM DIA 224001446 M/DN R-F IM NAIL 14MM DIA 224000922 M/DN R-F IM NAIL 9MM DIA 224000926 M/DN R-F IM NAIL 9MM DIA 224000928 M/DN R-F IM NAIL 9MM DIA 224000930 M/DN R-F IM NAIL 9MM DIA 224000932 M/DN R-F IM NAIL 9MM DIA 224000934 M/DN R-F IM NAIL 9MM DIA 224000936 M/DN R-F IM NAIL 9MM DIA 224000942 M/DN R-F IM NAIL 9MM DIA 224000946 M/DN R-F IM NAIL 9MM DIA 225320010 M/DN TIBIAL I/M NAIL 10MM 225326010 M/DN TIBIAL I/M NAIL 10MM 225328010 M/DN TIBIAL I/M NAIL 10MM 225330010 M/DN TIBIAL I/M NAIL 10MM 225332010 M/DN TIBIAL I/M NAIL 10MM 225334010 M/DN TIBIAL I/M NAIL 10MM 225336010 M/DN TIBIAL I/M NAIL 10MM 225338010 M/DN TIBIAL I/M NAIL 10MM 225344010 M/DN TIBIAL I/M NAIL 10MM 225320011 M/DN TIBIAL I/M NAIL 11MM 225322011 M/DN TIBIAL I/M NAIL 11MM 225324011 M/DN TIBIAL I/M NAIL 11MM 225326011 M/DN TIBIAL I/M NAIL 11MM 225328011 M/DN TIBIAL I/M NAIL 11MM 225330011 M/DN TIBIAL I/M NAIL 11MM 225332011 M/DN TIBIAL I/M NAIL 11MM 225334011 M/DN TIBIAL I/M NAIL 11MM 225336011 M/DN TIBIAL I/M NAIL 11MM 225338011 M/DN TIBIAL I/M NAIL 11MM 225340011 M/DN TIBIAL I/M NAIL 11MM 225342011 M/DN TIBIAL I/M NAIL 11MM 225344011 M/DN TIBIAL I/M NAIL 11MM 225346011 M/DN TIBIAL I/M NAIL 11MM 225328012 M/DN TIBIAL I/M NAIL 12MM 225330012 M/DN TIBIAL I/M NAIL 12MM 225332012 M/DN TIBIAL I/M NAIL 12MM 225334012 M/DN TIBIAL I/M NAIL 12MM 225336012 M/DN TIBIAL I/M NAIL 12MM 225338012 M/DN TIBIAL I/M NAIL 12MM 225340012 M/DN TIBIAL I/M NAIL 12MM 225346012 M/DN TIBIAL I/M NAIL 12MM 225324013 M/DN TIBIAL I/M NAIL 13MM

    FDA Recall
    Terminated ·Product code HSB·January 11, 2016

    Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MDN 02-RS-INSERTER-MDN 02-SCREWINS-CL-MDN 02-SCREWINS-C-MDN 02-S-FINDER-L-MDN 02-SFINDER-MDN 02-S-FINDER-T-MDN 02-TAP-45-MDN 02-TAP-55-MDN 02-TAP-60-L-MDN 02-TAP-65-L-MDN 02-TAP-65-MDN 02-TAP-75-L-MDN 02-TAP-75-MDN 02-TAP-85-L-MDN 02-TAP-85-MDN 02-TAP-95-L-MDN 02-MODHANDLE-MDN Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

    FDA Enforcement
    Class II ·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·November 4, 2020

    Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MDN 02-RS-INSERTER-MDN 02-SCREWINS-CL-MDN 02-SCREWINS-C-MDN 02-S-FINDER-L-MDN 02-SFINDER-MDN 02-S-FINDER-T-MDN 02-TAP-45-MDN 02-TAP-55-MDN 02-TAP-60-L-MDN 02-TAP-65-L-MDN 02-TAP-65-MDN 02-TAP-75-L-MDN 02-TAP-75-MDN 02-TAP-85-L-MDN 02-TAP-85-MDN 02-TAP-95-L-MDN 02-MODHANDLE-MDN Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

    FDA Recall
    Terminated ·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code OLO·September 24, 2020

    Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F IM NAIL 10MM DIA 224001020 M/DN R-F IM NAIL 10MM DIA 224001022 M/DN R-F IM NAIL 10MM DIA 224001024 M/DN R-F IM NAIL 10MM DIA 224001026 M/DN R-F IM NAIL 10MM DIA 224001028 M/DN R-F IM NAIL 10MM DIA 224001030 M/DN R-F IM NAIL 10MM DIA 224001032 M/DN R-F IM NAIL 10MM DIA 224001034 M/DN R-F IM NAIL 10MM DIA 224001036 M/DN R-F IM NAIL 10MM DIA 224001038 M/DN R-F IM NAIL 10MM DIA 224001040 M/DN R-F IM NAIL 10MM DIA 224001042 M/DN R-F IM NAIL 10MM DIA 224001114 M/DN R-F IM NAIL 11MM DIA 224001116 M/DN R-F IM NAIL 11MM DIA 224001118 M/DN R-F IM NAIL 11MM DIA 224001120 M/DN R-F IM NAIL 11MM DIA 224001122 M/DN R-F IM NAIL 11MM DIA 224001124 M/DN R-F IM NAIL 11MM DIA 224001126 M/DN R-F IM NAIL 11MM DIA 224001128 M/DN R-F IM NAIL 11MM DIA 224001130 M/DN R-F IM NAIL 11MM DIA 224001132 M/DN R-F IM NAIL 11MM DIA 224001134 M/DN R-F IM NAIL 11MM DIA 224001136 M/DN R-F IM NAIL 11MM DIA 224001138 M/DN R-F IM NAIL 11MM DIA 224001140 M/DN R-F IM NAIL 11MM DIA 224001142 M/DN R-F IM NAIL 11MM DIA 224001144 M/DN R-F IM NAIL 11MM DIA 224001146 M/DN R-F IM NAIL 11MM DIA 224001218 M/DN R-F IM NAIL 12MM DIA 224001220 M/DN R-F IM NAIL 12MM DIA 224001224 M/DN R-F IM NAIL 12MM DIA 224001226 M/DN R-F IM NAIL 12MM DIA 224001228 M/DN R-F IM NAIL 12MM DIA 224001230 M/DN R-F IM NAIL 12MM DIA 224001232 M/DN R-F IM NAIL 12MM DIA 224001234 M/DN R-F IM NAIL 12MM DIA 224001236 M/DN R-F IM NAIL 12MM DIA 224001238 M/DN R-F IM NAIL 12MM DIA 224001240 M/DN R-F IM NAIL 12MM DIA 224001242 M/DN R-F IM NAIL 12MM DIA 224001244 M/DN R-F IM NAIL 12MM DIA 224001248 M/DN R-F IM NAIL 12MM DIA 224001318 M/DN R-F IM NAIL 13MM DIA 224001324 M/DN R-F IM NAIL 13MM DIA 224001326 M/DN R-F IM NAIL 13MM DIA 224001328 M/DN R-F IM NAIL 13MM DIA 224001330 M/DN R-F IM NAIL 13MM DIA 224001332 M/DN R-F IM NAIL 13MM DIA 224001334 M/DN R-F IM NAIL 13MM DIA 224001336 M/DN R-F IM NAIL 13MM DIA 224001338 M/DN R-F IM NAIL 13MM DIA 224001340 M/DN R-F IM NAIL 13MM DIA 224001344 M/DN R-F IM NAIL 13MM DIA 224001346 M/DN R-F IM NAIL 13MM DIA 224001348 M/DN R-F IM NAIL 13MM DIA 224001422 M/DN R-F IM NAIL 14MM DIA 224001436 M/DN R-F IM NAIL 14MM DIA 224001438 M/DN R-F IM NAIL 14MM DIA 224001440 M/DN R-F IM NAIL 14MM DIA 224001442 M/DN R-F IM NAIL 14MM DIA 224001444 M/DN R-F IM NAIL 14MM DIA 224001446 M/DN R-F IM NAIL 14MM DIA 224000922 M/DN R-F IM NAIL 9MM DIA 224000926 M/DN R-F IM NAIL 9MM DIA 224000928 M/DN R-F IM NAIL 9MM DIA 224000930 M/DN R-F IM NAIL 9MM DIA 224000932 M/DN R-F IM NAIL 9MM DIA 224000934 M/DN R-F IM NAIL 9MM DIA 224000936 M/DN R-F IM NAIL 9MM DIA 224000942 M/DN R-F IM NAIL 9MM DIA 224000946 M/DN R-F IM NAIL 9MM DIA 225320010 M/DN TIBIAL I/M NAIL 10MM 225326010 M/DN TIBIAL I/M NAIL 10MM 225328010 M/DN TIBIAL I/M NAIL 10MM 225330010 M/DN TIBIAL I/M NAIL 10MM 225332010 M/DN TIBIAL I/M NAIL 10MM 225334010 M/DN TIBIAL I/M NAIL 10MM 225336010 M/DN TIBIAL I/M NAIL 10MM 225338010 M/DN TIBIAL I/M NAIL 10MM 225344010 M/DN TIBIAL I/M NAIL 10MM 225320011 M/DN TIBIAL I/M NAIL 11MM 225322011 M/DN TIBIAL I/M NAIL 11MM 225324011 M/DN TIBIAL I/M NAIL 11MM 225326011 M/DN TIBIAL I/M NAIL 11MM 225328011 M/DN TIBIAL I/M NAIL 11MM 225330011 M/DN TIBIAL I/M NAIL 11MM 225332011 M/DN TIBIAL I/M NAIL 11MM 225334011 M/DN TIBIAL I/M NAIL 11MM 225336011 M/DN TIBIAL I/M NAIL 11MM 225338011 M/DN TIBIAL I/M NAIL 11MM 225340011 M/DN TIBIAL I/M NAIL 11MM 225342011 M/DN TIBIAL I/M NAIL 11MM 225344011 M/DN TIBIAL I/M NAIL 11MM 225346011 M/DN TIBIAL I/M NAIL 11MM 225328012 M/DN TIBIAL I/M NAIL 12MM 225330012 M/DN TIBIAL I/M NAIL 12MM 225332012 M/DN TIBIAL I/M NAIL 12MM 225334012 M/DN TIBIAL I/M NAIL 12MM 225336012 M/DN TIBIAL I/M NAIL 12MM 225338012 M/DN TIBIAL I/M NAIL 12MM 225340012 M/DN TIBIAL I/M NAIL 12MM 225346012 M/DN TIBIAL I/M NAIL 12MM 225324013 M/DN TIBIAL I/M NAIL 13MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN

    FDA Enforcement
    Class II ·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·November 11, 2020

    Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

    FDA Enforcement
    Class II ·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·November 4, 2020

    Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM IM NAIL 10MM DIA 225230010 M/DN FEM IM NAIL 10MM DIA 225232010 M/DN FEM IM NAIL 10MM DIA 225234010 M/DN FEM IM NAIL 10MM DIA 225236010 M/DN FEM IM NAIL 10MM DIA 225238010 M/DN FEM IM NAIL 10MM DIA 225240010 M/DN FEM IM NAIL 10MM DIA 225242010 M/DN FEM IM NAIL 10MM DIA 225244010 M/DN FEM IM NAIL 10MM DIA 225246010 M/DN FEM IM NAIL 10MM DIA 225228011 M/DN FEM IM NAIL 11MM DIA 225230011 M/DN FEM IM NAIL 11MM DIA 225232011 M/DN FEM IM NAIL 11MM DIA 225234011 M/DN FEM IM NAIL 11MM DIA 225236011 M/DN FEM IM NAIL 11MM DIA 225238011 M/DN FEM IM NAIL 11MM DIA 225240011 M/DN FEM IM NAIL 11MM DIA 225242011 M/DN FEM IM NAIL 11MM DIA 225244011 M/DN FEM IM NAIL 11MM DIA 225246011 M/DN FEM IM NAIL 11MM DIA 225224012 M/DN FEM IM NAIL 12MM DIA 225232012 M/DN FEM IM NAIL 12MM DIA 225234012 M/DN FEM IM NAIL 12MM DIA 225236012 M/DN FEM IM NAIL 12MM DIA 225238012 M/DN FEM IM NAIL 12MM DIA 225240012 M/DN FEM IM NAIL 12MM DIA 225242012 M/DN FEM IM NAIL 12MM DIA 225244012 M/DN FEM IM NAIL 12MM DIA 225246012 M/DN FEM IM NAIL 12MM DIA 225228013 M/DN FEM IM NAIL 13MM DIA 225230013 M/DN FEM IM NAIL 13MM DIA 225232013 M/DN FEM IM NAIL 13MM DIA 225234013 M/DN FEM IM NAIL 13MM DIA 225236013 M/DN FEM IM NAIL 13MM DIA 225238013 M/DN FEM IM NAIL 13MM DIA 225240013 M/DN FEM IM NAIL 13MM DIA 225242013 M/DN FEM IM NAIL 13MM DIA 225244013 M/DN FEM IM NAIL 13MM DIA 225246013 M/DN FEM IM NAIL 13MM DIA 225236014 M/DN FEM IM NAIL 14MM DIA 225238014 M/DN FEM IM NAIL 14MM DIA 225240014 M/DN FEM IM NAIL 14MM DIA 225242014 M/DN FEM IM NAIL 14MM DIA 225244014 M/DN FEM IM NAIL 14MM DIA 225246014 M/DN FEM IM NAIL 14MM DIA 225234015 M/DN FEM IM NAIL 15MM DIA 225240015 M/DN FEM IM NAIL 15MM DIA 225242015 M/DN FEM IM NAIL 15MM DIA 225244015 M/DN FEM IM NAIL 15MM DIA 225242016 M/DN FEM IM NAIL 16MM DIA 225230008 M/DN FEM IM NAIL 8MM DIA 225232008 M/DN FEM IM NAIL 8MM DIA 225234008 M/DN FEM IM NAIL 8MM DIA 225238008 M/DN FEM IM NAIL 8MM DIA 225228009 M/DN FEM IM NAIL 9MM DIA 225230009 M/DN FEM IM NAIL 9MM DIA 225232009 M/DN FEM IM NAIL 9MM DIA 225234009 M/DN FEM IM NAIL 9MM DIA 225236009 M/DN FEM IM NAIL 9MM DIA 225238009 M/DN FEM IM NAIL 9MM DIA 225240009 M/DN FEM IM NAIL 9MM DIA 225242009 M/DN FEM IM NAIL 9MM DIA 225244009 M/DN FEM IM NAIL 9MM DIA 225418010 M/DN HUMERAL I/M NAIL 10M 225419510 M/DN HUMERAL I/M NAIL 10M 225421010 M/DN HUMERAL I/M NAIL 10M 225422510 M/DN HUMERAL I/M NAIL 10M 225424010 M/DN HUMERAL I/M NAIL 10M 225425510 M/DN HUMERAL I/M NAIL 10M 225427010 M/DN HUMERAL I/M NAIL 10M 225428510 M/DN HUMERAL I/M NAIL 10M 225430010 M/DN HUMERAL I/M NAIL 10M 225419511 M/DN HUMERAL I/M NAIL 11M 225421011 M/DN HUMERAL I/M NAIL 11M 225422511 M/DN HUMERAL I/M NAIL 11M 225424011 M/DN HUMERAL I/M NAIL 11M 225425511 M/DN HUMERAL I/M NAIL 11M 225427011 M/DN HUMERAL I/M NAIL 11M 225421012 M/DN HUMERAL I/M NAIL 12M 225422512 M/DN HUMERAL I/M NAIL 12M 225424012 M/DN HUMERAL I/M NAIL 12M 225425512 M/DN HUMERAL I/M NAIL 12M 225427012 M/DN HUMERAL I/M NAIL 12M 225428512 M/DN HUMERAL I/M NAIL 12M 225430012 M/DN HUMERAL I/M NAIL 12M 225418013 M/DN HUMERAL I/M NAIL 13M 225424013 M/DN HUMERAL I/M NAIL 13M 225427013 M/DN HUMERAL I/M NAIL 13M 225418006 M/DN HUMERAL I/M NAIL 6MM 225419506 M/DN HUMERAL I/M NAIL 6MM 225421006 M/DN HUMERAL I/M NAIL 6MM 225424006 M/DN HUMERAL I/M NAIL 6MM 225427006 M/DN HUMERAL I/M NAIL 6MM 225428506 M/DN HUMERAL I/M NAIL 6MM 225430006 M/DN HUMERAL I/M NAIL 6MM 225418007 M/DN HUMERAL I/M NAIL 7MM 225419507 M/DN HUMERAL I/M NAIL 7MM 225421007 M/DN HUMERAL I/M NAIL 7MM 225422507 M/DN HUMERAL I/M NAIL 7MM 225424007 M/DN HUMERAL I/M NAIL 7MM 225425507 M/DN HUMERAL I/M NAIL 7MM 225427007 M/DN HUMERAL I/M NAIL 7MM 225428507 M/DN HUMERAL I/M NAIL 7MM 225430007 M/DN HUMERAL I/M NAIL 7MM 225418008 M/DN HUMERAL I/M NAIL 8MM 225

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

    FDA Recall
    Terminated ·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code OLO·September 24, 2020

    Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN

    FDA Recall
    Terminated ·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code OLO·September 11, 2020

    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.

    FDA Enforcement
    Class II ·Terminated·LAP of America Laser Applications, LLC·June 11, 2014