Zimmer Biomet Recalls Nondegradable Soft Tissue Fixation Fasteners
Zimmer Biomet is recalling 429 units of nondegradable soft tissue fixation fasteners because the implant shaft may shift and fall out during device opening.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that could cause the device to break during use, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 429 units of nondegradable soft tissue fixation fasteners. The recall involves specific item and lot numbers distributed to facilities in Texas, North Carolina, Florida, Pennsylvania, Indiana, Wisconsin, Virginia, New York, New Jersey, Alabama, and Connecticut.
The recall was initiated because the product was not assembled correctly. This defect causes the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
Healthcare providers and consumers should stop using the affected fasteners and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- fastener, fixation, nondegradable, soft tissue
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 429
Distribution
Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12