Recall Z-1138-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Corporation
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
| Date | Feb 11, 2025 (initiated Jan 8, 2025) |
| Status | Open, Classified |
| Reason | Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 622 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143145 | SafeAir Smoke Pencil Lina Medical Aps, Dec 4, 2014 |