FDA-Device2026-02-11Class IIMISBRANDING

Tornier Perform Reversed Periph Screw recalled for incorrect labeling and size mismatch

LABEL MIX UPNationwide distribution

Check Tornier orthopedic screws for size mismatch

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
Hazard

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.

Sold states
US Nationwide distribution.
Affected count
427
Manufactured in
10801 Nesbitt Ave S, N/A, Bloomington, MN, United States
Products
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2026

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