FDAClass IIFebruary 11, 2026

Tornier Perform Reversed Perip Screw 5.0mmx18mm NON recall

TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

Why was Tornier Perform Reversed Perip Screw 5.0mmx18mm NON recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot AZ4824290

Product
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Recalling firm
Tornier, Inc
Quantity
427
Distribution
US Nationwide distribution.
Recall date
February 11, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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