Recall Z-0581-2025 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Smith & Nephew Inc.
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
| Date | Nov 29, 2024 (initiated Oct 29, 2024) |
| Status | Open, Classified |
| Reason | Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. |
| Root cause | Package design/selection |
| Action | An URGENT MEDICAL DEVICE RECALL NOTICE dated 10/29/24 was mailed to consignees. This notification instructed consignees to inspect their inventory for affected devices and quarantine them immediately. If product was further distributed consignees are to notify their customers of this recall and ensure recall actions are completed. Consignees are to complete the provided response form to facilitate the return of devices and email the completed form to FieldActions@smith-nephew.com. Consignees who do not have product on hand are to complete and return the recall response form as well. Any questi |
| Quantity | 2,156 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR. |
| FDA record | Open on fda.gov |