Tornier Perform Reversed Periph Screw recalled for incorrect labeling and size mismatch
What this means
A specific lot of Tornier surgical screws (catalog DWJ318, lot AZ4824290) is labeled as 5.0mm×18mm but actually contains 5.0mm×14mm screws. If the wrong size is used without detection during surgery, it could increase the risk of mechanical failure and the need for revision surgery.
- If you received screws from lot AZ4824290, verify the actual size matches the label before use
- Contact Tornier or your supplier immediately if you have this lot in inventory
- During any procedure using these screws, confirm screw dimensions before implantation
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2026Want us to check the next one for you?
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