TORNIER PERFORM REVERSED PERIP SCREW 5 — Class II medical device recall Z-1237-2026
Ongoing recall by Tornier, Inc, reported 2026-02-11, distributed nationwide. A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mm
| Recall number | Z-1237-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier, Inc, Bloomington, MN, United States |
| Recall initiated | 2025-12-19 |
| Classified | 2026-02-02 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 427 |
| Reason classes | labeling |
| Lot numbers | AZ4824290 |
| Model numbers | DWJ318 |
Product
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Reason for recall
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
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-1237-2026. 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.