Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 61 of 125
Howmedica Osteonics Corp.
Class II Terminated
Radial Head Assy Size #4, Rad. 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-2699-2018 August 15, 2018 Mahwah, NJ
New Era Orthopaedics, LLc
Class II Terminated
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Reason: This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which e...
Z-2604-2018 August 15, 2018 Hummelstown, PA
Howmedica Osteonics Corp.
Class II Terminated
rHead Recon Stem Implant Plasma 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-2686-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
Lat Assembly, Rad Stem Implant,Collar 6mm,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-2668-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead, Radial Implant 6 mm 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-2730-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
Radio Capitellum, Recon Head, 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-2701-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Stem Implant Plasma Coated, 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-2679-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
radial stem implant #3 (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-2729-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
radial head implant #3 (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-2723-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
Radial Head Assy Size #3, Rad. 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-2698-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
Radio Capitellum Large, 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-2693-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Recon 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-2691-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
Lateral Assembly, Radial Head Implant, 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-2673-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
radial head implant #4 (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-2724-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
Radial Head Assy Size #2, Rad. 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-2697-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Recon Stem Implant non-coated, 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-2721-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
#3 Bipolar radial head 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-2712-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
#2 Bipolar radial head 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-2711-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
Lateral Assembly, Radial Head Implant, 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-2671-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Standard Extended Stem, 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-2704-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Stem Implant Plasma Coated, 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-2677-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Stem Implant Plasma Coated, 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-2680-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
#4 Bipolar radial head 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-2713-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Recon Stem Implant Plasma Coated, 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-2687-2018 August 15, 2018 Mahwah, NJ
Howmedica Osteonics Corp.
Class II Terminated
rHead Stem Implant Plasma 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-2678-2018 August 15, 2018 Mahwah, NJ