Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 59 of 125
Boston Scientific Corporation
Class II Terminated
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Sc...
Reason: There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
Z-3260-2018 October 3, 2018 Saint Paul, MN
Zimmer Biomet, Inc.
Class II Terminated
Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty
Reason: The implant only has one bolt in the sterile package but it should have had two.
Z-3250-2018 October 3, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
Reason: The implant only has one bolt in the sterile package but it should have had two.
Z-3249-2018 October 3, 2018 Warsaw, IN
Zimmer Dental Inc
Class II Terminated
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Im...
Reason: Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
Z-2963-2018 September 12, 2018 Carlsbad, CA
Inspire Medical Systems Inc.
Class II Terminated
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Sti...
Reason: Incorrect use-by date on the device registration/patient file labels.
Z-2969-2018 September 12, 2018 Maple Grove, MN
Apollo Endosurgery Inc
Class II Terminated
Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the b...
Reason: Component of the Lap-Band system was missing from the package
Z-2743-2018 August 22, 2018 West Lake Hills, TX
Merit Medical Systems, Inc.
Class II Terminated
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck¿ PD Catheter can be implanted ...
Reason: Mix-up between adult and pediatrics PD catheter.
Z-2823-2018 August 22, 2018 South Jordan, UT
Sorin CRM SAS
Class II Terminated
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Reason: Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrilla...
Z-2824-2018 August 22, 2018 Clamart Cedex
Sorin CRM SAS
Class II Terminated
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Reason: Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrilla...
Z-2825-2018 August 22, 2018 Clamart Cedex
Howmedica Osteonics Corp.
Class II Terminated
Radio Capitellum Small, Left. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2694-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
#4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2720-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2703-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
radial head implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2722-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2676-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
Radio Capitellum Broach Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2710-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2682-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2672-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2717-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2706-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2683-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead, Radial Implant 6 mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2726-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2705-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2690-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2667-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2663-2018 August 15, 2018 Mahwah, NJ