Class II — Smith & Nephew Inc.
| Recalling firm | Smith & Nephew, Inc. |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. |
| Product | BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. |
| 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. |
| Initiated | 2024-10-29 |
| Classified | 2024-11-29 |
| Recall number | Z-0581-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Smith & Nephew Inc. (Z-0581-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95654/
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