Smith & Nephew T-F1X0 RCG Drill Pac — Class II medical device recall Z-2702-2020
Ongoing recall by Smith & Nephew, Inc., reported 2020-08-05, distributed nationwide. The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for
| Recall number | Z-2702-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Andover, MA, United States |
| Recall initiated | 2020-06-24 |
| Classified | 2020-07-24 |
| Reported by FDA | 2020-08-05 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| Lot numbers | 2042492, 2049408 |
| Model numbers | 014771 |
Product
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771
Reason for recall
The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
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-2702-2020. 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.