Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 90 of 125
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. Reamer.
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1820-2016 June 1, 2016 Warsaw, IN
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. Passer.
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1824-2016 June 1, 2016 Warsaw, IN
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. Arthroscope.
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1818-2016 June 1, 2016 Warsaw, IN
Biomet, Inc.
Class II Terminated
Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
Reason: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If t...
Z-1828-2016 June 1, 2016 Warsaw, IN
Zimmer Manufacturing B.V.
Class II Terminated
Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Thr...
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Z-1677-2016 May 25, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225...
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Z-1678-2016 May 25, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625006515 Bone screw 6.5x20 selftap 00625006520 Bone screw...
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Z-1684-2016 May 25, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Z-1682-2016 May 25, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bon...
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Z-1680-2016 May 25, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Le...
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Z-1673-2016 May 25, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Z-1675-2016 May 25, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Z-1676-2016 May 25, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Z-1681-2016 May 25, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bo...
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Z-1679-2016 May 25, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acet...
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Z-1683-2016 May 25, 2016 Mercedita, PR
Zimmer Manufacturing B.V.
Class II Terminated
Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Z-1674-2016 May 25, 2016 Mercedita, PR
Baxter Healthcare Corp.
Class II Terminated
GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end...
Reason: Instructions for use booklet may puncture the outer Tyvek lid.
Z-1627-2016 May 18, 2016 Deerfield, IL
Baxter Healthcare Corp.
Class II Terminated
GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the en...
Reason: Instructions for use booklet may puncture the outer Tyvek lid.
Z-1628-2016 May 18, 2016 Deerfield, IL
Stryker Corporation
Class II Terminated
CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degr...
Reason: Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking upon deploy...
Z-1635-2016 May 18, 2016 San Jose, CA
Baxter Healthcare Corp.
Class II Terminated
GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-t...
Reason: Instructions for use booklet may puncture the outer Tyvek lid.
Z-1630-2016 May 18, 2016 Deerfield, IL
Baxter Healthcare Corp.
Class II Terminated
GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end...
Reason: Instructions for use booklet may puncture the outer Tyvek lid.
Z-1631-2016 May 18, 2016 Deerfield, IL
Stanmore Implants Worldwide Ltd.
Class II Terminated
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Reason: Incorrect component used to manufacture distal femoral replacement.
Z-1623-2016 May 18, 2016 Borehamwood, N/A
St Jude Medical Inc.
Class II Terminated
Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pac...
Reason: St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.
Z-1632-2016 May 18, 2016 Sylmar, CA
Atlas Spine, Inc.
Class II Terminated
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Reason: The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Z-1616-2016 May 18, 2016 Jupiter, FL
Stryker Corporation
Class II Terminated
CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degra...
Reason: Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking upon d...
Z-1634-2016 May 18, 2016 San Jose, CA