Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 109 of 125
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device ...
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Z-0860-2014 February 5, 2014 Raynham, MA
ACUTE Innovations, LLC
Class II Terminated
The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing pro...
Reason: The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery.
Z-0852-2014 February 5, 2014 Hillsboro, OR
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides consta...
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Z-0861-2014 February 5, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device...
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Z-0862-2014 February 5, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pre...
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Z-0858-2014 February 5, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable de...
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Z-0863-2014 February 5, 2014 Raynham, MA
Navilyst Medical, Inc.
Class II Terminated
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalo...
Reason: Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.
Z-0826-2014 February 5, 2014 Marlborough, MA
Zimmer Dental Inc
Class II Terminated
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
Reason: Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have t...
Z-0847-2014 February 5, 2014 Carlsbad, CA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides con...
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Z-0859-2014 February 5, 2014 Raynham, MA
Bard Access Systems
Class II Terminated
MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Ac...
Reason: Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr ...
Z-0814-2014 January 29, 2014 Salt Lake City, UT
Ziemer Usa Inc
Class II Terminated
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring ...
Reason: A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.
Z-0811-2014 January 29, 2014 Alton, IL
Bard Access Systems
Class II Terminated
Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into vario...
Reason: Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr ...
Z-0815-2014 January 29, 2014 Salt Lake City, UT
Sorin Group Italia S.r.l.
Class II Terminated
ORCHESTRA/ORCHESTRA PLUS Programmer
Reason: Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a...
Z-0805-2014 January 29, 2014 Saluggia, VC
SpineFrontier, Inc.
Class II Terminated
Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-810...
Reason: Handles and heads may not be compatible.
Z-0776-2014 January 22, 2014 Beverly, MA
SpineFrontier, Inc.
Class II Terminated
Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactur...
Reason: Handles and heads may not be compatible.
Z-0777-2014 January 22, 2014 Beverly, MA
Biomet, Inc.
Class II Terminated
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Reason: 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locki...
Z-0716-2014 January 22, 2014 Warsaw, IN
SpineFrontier, Inc.
Class II Terminated
Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 S...
Reason: Handles and heads may not be compatible.
Z-0778-2014 January 22, 2014 Beverly, MA
RTI Surgical, Inc.
Class II Terminated
C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to ...
Reason: As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requ...
Z-0627-2014 January 15, 2014 Marquette, MI
Aesculap, Inc.
Class II Terminated
Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
Reason: The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.
Z-0492-2014 December 25, 2013 Center Valley, PA
SpineFrontier, Inc.
Class II Terminated
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of t...
Reason: During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip h...
Z-0544-2014 December 25, 2013 Beverly, MA
Zimmer, Inc.
Class II Terminated
Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preser...
Reason: As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of contain...
Z-0477-2014 December 18, 2013 Warsaw, IN
Stryker Howmedica Osteonics Corp.
Class II Terminated
Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40...
Reason: Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.
Z-0483-2014 December 18, 2013 Mahwah, NJ
Zimmer, Inc.
Class II Terminated
NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and ...
Reason: This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro compon...
Z-0459-2014 December 18, 2013 Warsaw, IN
Zimmer, Inc.
Class II Terminated
NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disab...
Reason: This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro compon...
Z-0463-2014 December 18, 2013 Warsaw, IN
Zimmer, Inc.
Class II Terminated
NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability ...
Reason: This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro compon...
Z-0461-2014 December 18, 2013 Warsaw, IN