FDA-Device2026-02-11Class II
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Tornier, Inc
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-1237-2026Don't want to check this manually?
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