United StatesTornier Perform Reversed Perip Screw 5.0mm x 18mm (catalog DWJ318), lot AZ4824290 (427 units distributed nationwide in the U.S.), is labeled 5.0mm x 18mm but the actual screws are 5.00mm x 14mm. The screws were recalled because the incorrect labeling can cause a minor surgical delay if detected, and if undetected and the wrong screw is used it may increase the risk of earlier mechanical failure, loosening, and need for revision surgery.
What's being recalled
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Recalling firm: Tornier, Inc, Bloomington, MN, United States.
How to identify it
Lot AZ4824290
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)