FDA Medical devices recall ·
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE… recall
- Recall number
- Z-1237-2026
- Date
- (initiated December 19, 2025)
- Company / brand
- Tornier, Inc
10801 Nesbitt Ave S, Bloomington, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 427
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot AZ4824290
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1237-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.