114 results
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13ms
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Sources: EU EUDAMED, US FDA
GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
FDA Recall
Terminated
·Verathon, Inc.·Product code CCW·March 31, 2019
Stryker Instruments 8.omm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-180.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008
GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.
FDA Recall
Terminated
·Verathon, Inc.·Product code CCW·April 13, 2015
BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.
FDA Recall
Terminated
·Verathon, Inc.·Product code IYO·November 30, 2015
PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R J +6MM; and
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·August 7, 2014
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J BOTTOM, +6MM TASP R CD BOTTOM, +0MM TASP R CD BOTTOM, +6MM TASP R EF BOTTOM, +0MM TASP R EF BOTTOM, +6MM TASP R GH BOTTOM, +0MM TASP R GH BOTTOM, +6MM TASP R J BOTTOM, +0MM TASP R J BOTTOM, +6MM
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 10, 2013
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 0mm CAT 04-33-0001; SIZE 2 x 0mm CAT 04-33-0002; SIZE 3 x 0mm CAT 04-33-0003; SIZE 4 x 0mm CAT 04-33-0004; SIZE 5 x 0mm CAT 04-33-0005; SIZE 6 x 0mm CAT 04-33-0006. Tricompartmental Knee Replacement
FDA Recall
Terminated
·Endotec, Inc.·Product code NRA·September 21, 2011
PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J +6 mm TB; Right Size 1-2 CD +0 mm TB; Right Size CD +6 mm TB; Right Size EF +0 mm TB; Right Size EF +6 mm TB; Right Size GH +0 mm TB; Right Size GH +6 mm TB; Right Size J +0 mm TB; and Right Size J +6 mm TB.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·August 7, 2014
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTTOM +0MM PSN A/S PROV L EF BOTTOM +6MM PSN A/S PROV L GH BOTTOM +0MM PSN A/S PROV L GH BOTTOM +6MM PSN A/S PROV L J BOTTOM +0MM PSN A/S PROV L J BOTTOM +6MM PSN A/S PROV R CD BOTTOM +0MM PSN A/S PROV R CD BOTTOM +6MM PSN A/S PROV R EF BOTTOM +0MM PSN A/S PROV R EF BOTTOM +6MM PSN A/S PROV R GH BOTTOM +0MM PSN A/S PROV R GH BOTTOM +6MM PSN A/S PROV R J BOTTOM +0MM PSN A/S PROV R J BOTTOM +6MM
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 10, 2013
Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-01000R); c) Large/0MM Step/Left (002-C-02000L); d) Large/0MM Step/Right (002-C-02000R); e) Small/2MM Step/Left (002-C-01002L); f) Small/2MM Step/Right (002-C-01002R); g) Large/2MM Step/Left (002-C-02002L); h) Large/2MM Step/Right (002-C-02002R)
FDA Recall
Terminated
·Orthofix, Inc·Product code HRS·April 6, 2018
Femoral head, standard, 26mm, +0mm Femoral head,medium, 26mm,+3mm Femoral head, long, 26mm, +6mm Femoral head, X-long, 26mm, +9mm Femoral head, 28mm, -3mm Femoral head, 28mm, +0mm Femoral head, 28mm, +5mm Femoral head, 28mm, +10mm Femoral head, 32mm, -3mm Femoral head, 32mm, +0mm Femoral head, 32mm, +5mm Femoral head, 32mm, +10mm Femoral head, 36mm, -3mm Femoral head, 36mm, +0mm Femoral head, 36mm, +5mm Femoral head, 36mm, +10mm Variety of hip and knee implants and instruments, multiple uses.
FDA Recall
Terminated
·Orthopedic Alliance LLC·Product code LPH·February 20, 2013
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
FDA Recall
Terminated
·Keystone Dental Inc·Product code NHA·July 5, 2011
Depuy brand ACE trochanteric nail end cap, non-sterile, 0 mm; Product 903008000.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code HSB·December 11, 2003
Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LZO·June 30, 2017
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R. Orthopedic use.
FDA Recall
Terminated
·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.
FDA Recall
Terminated
·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015
Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDG·September 4, 2009
Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.
FDA Recall
Terminated
·C.R. Bard Access Systems, Inc·Product code MPB·August 10, 2007
Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
FDA Recall
Terminated
·Biomet Spine, LLC·Product code KWQ·August 5, 2015