FDA recall, , Moderate risk
Tornier Perform Reversed Perip Screw
Screws labeled 5.0mmx18mm are actually 5.00mmx14mm, which may cause a delay or increase risk of failure.
Summary by Recall Canary from the FDA notice
What happened
Tornier, Inc., of Bloomington, Minnesota, recalled a specific lot of Tornier Perform Reversed Perip Screw 5.0MMX18MM NON Sterile, because the screws are incorrectly labeled as 5.0mmx18mm but are actually 5.00mmx14mm.
If the mismatch is detected during surgery, the issue may cause a minor delay; if not detected and the incorrect screw is used, it may increase the risk of earlier mechanical failure, loosening, and need for revision surgery. The recall began December 19, 2025, and was added to the FDA's Enforcement Report on February 2, 2026, with US Nationwide distribution.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its lot code matches.
Tornier Perform Reversed Perip Screw 5.0MMX18MM NON Sterile, Catalog Number DWJ318
- Lot code
- AZ4824290
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Tornier, IncBloomington, Minnesota
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98123
- Recall number
- Z-1237-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
