stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
FDA device recall Z-1139-2025 · posted 2025-02-11 · Open, Classified
Recall details
- Recalling firm
- Stryker Corporation
- Reason for recall
- Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
- Action taken
- Stryker issued an URGENT MEDICAL DEVICE recall notice to its consignees on 01/08/2025 via FedEx. The notice explained the issue, potential risk, and requested the affected items be quarantined pending return. Stryker will issue a shipping label to the consignee once the response form has been received. Distributors were directed to forward the notice to all those to whom the affected devices were distributed.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- GEI
- Quantity affected
- 238 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2025-01-08
- Date posted
- 2025-02-11
- Location
- Portage, MI
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