TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
FDA device recall Z-1237-2026 · posted 2026-02-02 · Open, Classified
Recall details
- Recalling firm
- Tornier, Inc
- 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.
- Action taken
- On December 19, 2025, the firm began notifying affected customers via Urgent Field Safety Notice letters. Customers were instructed to immediately check their internal inventory for affected product. Firm stated that return of product is not necessary because the issue is detectable pre-operatively. The physical product itself is correctly marked, and after unpacking, should only be assigned to the correct place in the screw caddy. The notification is being provided for awareness only.
- Root cause
- Labeling mix-ups
- Status
- Open, Classified
- Product code
- KWS
- Quantity affected
- 427
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-12-19
- Date posted
- 2026-02-02
- Location
- Bloomington, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid (K161742) | Tornier, Inc. | 2016-11-15 |