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 | Terminated |
| Reason | Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device. |
| Product | TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone. |
| Quantity | 82 distributed throughout US:AZ, ID, MO, NC, ND, NE, OK, SC, TN. 243 distributed OUS: AE, AU, CA, CH, ES, FI, JP, PR, SG. Total: 325 units |
| Distribution | Worldwide distribution US Nationwide distribution in the states of AZ, ID, MO, NC, ND, NE, OK, SC, TN, and countries of AE, AU, CA, CH, ES, FI, JP, PR, SG. |
| Initiated | 2019-12-30 |
| Classified | 2020-02-19 |
| Terminated | 2021-05-11 |
| Recall number | Z-1273-2020 |
| 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-1273-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84748/
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