—#211998

Product

stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K143145
Affected lot / code info: GTIN 04546540046482, Lot Number 22298017

Why it was recalled

Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Stryker Corporation
Address: 1941 Stryker Way, Portage, Michigan 49002-9711

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2025-01-08
Posted by FDA: 2025-02-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211998. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.