Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 106 of 125
The Anspach Effort, Inc.
Class II Terminated
ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems
Reason: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Z-1918-2014 July 2, 2014 Palm Beach Gardens, FL
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1771-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1750-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as we...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1777-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surge...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1760-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surge...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1758-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surge...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1759-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surg...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1765-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1779-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surge...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1755-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surge...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1754-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well a...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1753-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well a...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1772-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear,...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1770-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surg...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1764-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well a...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1773-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear,...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1769-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well a...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1749-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal su...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1776-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well a...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1752-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal su...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1774-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surg...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1763-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal sur...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1778-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, n...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1766-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surge...
Reason: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Z-1756-2014 June 18, 2014 Portage, MI