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    RSP Baseplate Rim Planer (Size 32, 36, 40): DJO Surgical Instruments and Instrument Cases DJO surgical Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 Contact information: DJO Surgical, ATTN: Customer Service, 9800 Metric Blvd, Austin, TX 78758, 1-800-456-8696 The Baseplate Rim Planer is used to prepare the bone around the peripheral rim of the reamed socket. It has a spring loaded alignment pin on the proximal (cutting) end used in both alignment of the planer and as an indication that the planer has been seated fully.

    FDA Recall
    Terminated ·Product code LXH·September 28, 2011

    Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWA·September 30, 2013

    REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technologist review and audit. Key processing for specialized exams, totally automated processing for hands off operation. Centralized workflow device for dispersed readers environments. HIS/RIS patient status updates. Demographic Correction.

    FDA Recall
    Terminated ·Konica Minolta Medical Imaging USA, Inc.·Product code LLZ·February 6, 2006

    5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments. The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.

    FDA Recall
    Terminated ·Abbott Molecular·Product code JJH·June 19, 2014

    RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument Cases DJO surgical Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 Contact information: DJO Surgical, ATTN: Customer Service, 9800 Metric Blvd, Austin, TX 78758, 1-800-456-8696. The product is intended to be used to ream prepare the humeral bone for accepting the implant. It has a spring loaded alignment pin on the proximal (reaming) end used in both alignment of the reamer and as an indication that the reamer has been seated fully.

    FDA Recall
    Terminated ·Product code LXH·September 28, 2011

    Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, 46580.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LPH·October 19, 2007

    Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWA·September 30, 2013

    Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of this component.

    FDA Recall
    Terminated ·Product code LPH·January 12, 2006

    Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the conserve metal head

    FDA Recall
    Terminated ·MicroPort Orthopedics Inc.·Product code LZO·June 21, 2016

    OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07, 020-963-01)

    FDA Recall
    Terminated ·Lifescan Inc·Product code NBW·March 22, 2007

    Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation

    FDA Recall
    Terminated ·Product code HTT·May 11, 2017

    Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXT·January 29, 2016

    VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment.

    FDA Recall
    Terminated ·Maquet SAS Parc De Limere Avenue De La Pomme De Pin Orleans France·Product code FTD·April 19, 2018

    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code HSB·February 24, 2015

    VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.

    FDA Recall
    Terminated ·Maquet SAS Parc De Limere Avenue De La Pomme De Pin Orleans France·Product code FTD·June 14, 2018

    Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code FZX·February 17, 2015

    Bard Mesh Monofilament Knitted Polypropylene; size 10 x 14", 3 units per box; Davol Inc., A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.

    FDA Recall
    Terminated ·Ram Medical Inc·Product code FTL·March 5, 2010

    Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.

    FDA Recall
    Terminated ·Kim's Trading Inc·Product code LPM·May 17, 2010

    Bard Mesh Monofilament Knitted Polypropylene Flat Mesh; size 6" x 6", 3 per box; Davol Inc., Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.

    FDA Recall
    Terminated ·Ram Medical Inc·Product code FTL·March 5, 2010

    Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. Davol Inc. A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.

    FDA Recall
    Terminated ·Ram Medical Inc·Product code FTL·March 5, 2010