TwinFix Ti 2 — Class II medical device recall Z-1273-2020
Terminated recall by Smith & Nephew, Inc., reported 2020-02-26, distributed nationwide. Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of
| Recall number | Z-1273-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Mansfield, MA, United States |
| Recall initiated | 2019-12-30 |
| Classified | 2020-02-19 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2021-05-11 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| Lot numbers | 2010547, 2025137, 2036695, 50763859, 50773071 |
| Model numbers | 72200796 |
Product
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1273-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.