Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 107 of 125
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 6.0mm 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-1767-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 2.0mm 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 wel...
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-1751-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 2.0mm Tapered Round Elite 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 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-1761-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 3.5mm 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-1762-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 4.5mm 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-1757-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 3.0mm x 3.8mm 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 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-1775-2014 June 18, 2014 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spin...
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-1780-2014 June 18, 2014 Portage, MI
Medtronic Neuromodulation
Class II Terminated
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the i...
Reason: Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
Z-1723-2014 June 11, 2014 Minneapolis, MN
Synthes, Inc.
Class II Terminated
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: ...
Reason: Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.
Z-1669-2014 June 4, 2014 West Chester, PA
Biomet, Inc.
Class II Terminated
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Reason: This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening fr...
Z-1615-2014 May 21, 2014 Warsaw, IN
HeartWare Inc
Class II Terminated
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-sta...
Reason: Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.
Z-1607-2014 May 21, 2014 Miami Lakes, FL
Codman & Shurtleff, Inc.
Class II Terminated
MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal deli...
Reason: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
Z-1571-2014 May 21, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal deli...
Reason: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
Z-1572-2014 May 21, 2014 Raynham, MA
Medtronic Neuromodulation
Class II Terminated
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtroni...
Reason: Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. The...
Z-1568-2014 May 14, 2014 Minneapolis, MN
SpineFrontier, Inc.
Class II Terminated
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, I...
Reason: It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument frag...
Z-1565-2014 May 14, 2014 Beverly, MA
Teleflex Medical
Class II Terminated
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a...
Reason: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Z-1560-2014 May 14, 2014 Durham, NC
Medtronic Neuromodulation
Class II Terminated
Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers ...
Reason: This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening ov...
Z-1570-2014 May 14, 2014 Minneapolis, MN
Acumed LLC
Class II Terminated
The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50....
Reason: Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.
Z-1516-2014 May 7, 2014 Hillsboro, OR
Acumed LLC
Class II Terminated
The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7...
Reason: Manufacturing of these devices with a grade of stainless steel that is not within specifications.
Z-1515-2014 May 7, 2014 Hillsboro, OR
Zimmer, Inc.
Class II Terminated
TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.
Reason: The shell was missing the locking ring.
Z-1496-2014 April 30, 2014 Warsaw, IN
HeartWare Inc
Class I Terminated
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at ...
Reason: The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
Z-1471-2014 April 30, 2014 Miami Lakes, FL
Pega Medical Inc.
Class II Terminated
Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
Reason: The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.
Z-1472-2014 April 30, 2014 Laval, N/A
Biomet 3i, LLC
Class II Terminated
BIOMET 3i Endosseous Dental Implant.
Reason: Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
Z-1458-2014 April 23, 2014 Palm Beach Gardens, FL
Codman & Shurtleff, Inc.
Class II Terminated
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Uniti...
Reason: Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valve...
Z-1468-2014 April 23, 2014 Raynham, MA
Pega Medical Inc.
Class II Terminated
Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.
Reason: The Male Components in this lot are made of material with lower strength than manufacturing specifications.
Z-1448-2014 April 16, 2014 Laval, N/A