Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 78 of 125
Aesculap Implant Systems LLC
Class II Terminated
GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
Reason: Generators may have a faulty component which could impact the proper functioning of the device.
Z-1218-2017 February 22, 2017 Center Valley, PA
Stryker Leibinger GmbH & Co. KG
Class II Terminated
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal D...
Reason: An incorrect sterility status on the label, non-sterile products labeled as sterile
Z-1150-2017 February 15, 2017 Freiburg, N/A
Encore Medical, Lp
Class II Terminated
Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial bas...
Reason: The Empowr PS Insert was reported as missing the impaction slot feature.
Z-1139-2017 February 15, 2017 Austin, TX
Vertebral Technologies, Inc.
Class II Terminated
InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse...
Reason: Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfuse T tailed implant. The InterFuse T Tail may not fit into the Thru Hole in the ins...
Z-1151-2017 February 15, 2017 Minneapolis, MN
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
SwishTapered Implant
Reason: The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy m...
Z-1112-2017 February 8, 2017 Westlake Village, CA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pace...
Reason: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Z-0923-2017 February 1, 2017 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies),...
Reason: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Z-0924-2017 February 1, 2017 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomie...
Reason: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Z-0925-2017 February 1, 2017 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pace...
Reason: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Z-0922-2017 February 1, 2017 Andover, MA
Straumann Manufacturing, Inc.
Class II Terminated
Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical den...
Reason: Drills cannot be inserted into handpiece due to tolerance specification not met
Z-0958-2017 January 18, 2017 Andover, MA
Straumann Manufacturing, Inc.
Class II Terminated
Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental implants drill accessory is intended to prepare osteotomy site for surgical d...
Reason: Drills cannot be inserted into handpiece due to tolerance specification not met
Z-0957-2017 January 18, 2017 Andover, MA
ConforMIS, Inc.
Class II Terminated
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and d...
Reason: iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Z-0991-2017 January 18, 2017 Bedford, MA
Alcon Research, Ltd.
Class II Terminated
Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
Reason: The intraocular lens could become lodged within the cartridge
Z-0978-2017 January 18, 2017 Fort Worth, TX
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
GoDirect Screw-Retaining Top Part Numbers: 4500-61
Reason: Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.
Z-0961-2017 January 18, 2017 Westlake Village, CA
Bard Access Systems
Class II Terminated
MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc¿ trays per case and 160 per carton. Pro...
Reason: Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site d...
Z-0985-2017 January 18, 2017 Salt Lake City, UT
Zimmer Biomet, Inc.
Class II Terminated
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum seale...
Reason: Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package...
Z-0956-2017 January 18, 2017 Warsaw, IN
Bard Access Systems
Class II Terminated
SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. Product Usage:...
Reason: Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site d...
Z-0986-2017 January 18, 2017 Salt Lake City, UT
Medtronic Inc., Cardiac Rhythm and Heart Failure
Class II Terminated
Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat e...
Reason: During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices m...
Z-0962-2017 January 18, 2017 Mounds View, MN
Stryker Howmedica Osteonics Corp.
Class II Terminated
Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg...
Reason: Reunion TSA Peg Alignment Sound broke during surgery.
Z-1020-2017 January 18, 2017 Mahwah, NJ
Aesculap Implant Systems LLC
Class II Terminated
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
Reason: Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
Z-0947-2017 January 11, 2017 Center Valley, PA
Smith & Nephew, Inc.
Class II Terminated
Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have fa...
Reason: All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
Z-0944-2017 January 11, 2017 Memphis, TN
Interventional Spine Inc
Class II Terminated
G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervert...
Reason: During implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device f...
Z-0941-2017 January 11, 2017 Irvine, CA
Smith & Nephew, Inc.
Class II Terminated
Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilita...
Reason: All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
Z-0946-2017 January 11, 2017 Memphis, TN
Smith & Nephew, Inc.
Class II Terminated
Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilit...
Reason: All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
Z-0945-2017 January 11, 2017 Memphis, TN
MicroPort Orthopedics Inc.
Class II Terminated
PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for pre...
Reason: The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues t...
Z-0943-2017 January 11, 2017 Arlington, TN