Tornier, Inc recalls TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE,
Recalled Product
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Hazard / Issue
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.
Issued by
FDA
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