Recall Z-1139-2025
Stryker Corporation · initiated January 8, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Codes / lots: GTIN 04546540466549, Lot Number 23070017
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.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1139-2025
- Initiated
- January 8, 2025
- Posted by FDA
- February 11, 2025
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 238 units
- Distribution
- Worldwide distribution.
- Recalling firm
- Stryker Corporation, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1138-2025 Class II | stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal…Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them… | 01/08/2025Open, Classified |