Lower riskMedical device recall · FDA · Published December 19, 2025
Tornier Perip Screw Recall: Incorrect Labeling May Cause Surgery Delays
Tornier recalls specific lot of perip screws (DWJ318, Lot AZ482: 5.0mmx18mm labeled but 5.00mmx14mm actual). Mismatch risks surgery delays or revision surgery. No remedy provided.
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.
Take action
Contact the company
📍Recalling firmTornier, Inc10801 Nesbitt Ave S · Bloomington, MN 55437-3109
“Tornier Perip Screw Recall: Incorrect Labeling May Cause Surgery Delays.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50383-tornier-perip-screw-recall-incorrect-labeling-may-cause-surgery-delays. Based on FDA recall #Z-1237-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1237-2026%22&limit=1).
The FDA announced on Dec. 19, 2025, that Tornier, Inc. is recalling TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE due to labeling errors. The hazard involves a mismatch between labeled and actual screw lengths, which may cause surgical delays or increase the risk of mechanical failure. GovInfoNow's records show this voluntary Class II recall affects 427 units distributed nationwide.
How to tell if you have it
Brand: Tornier
Product: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE
Catalog number: DWJ318
Lot code: AZ4824290
The hazard
According to the FDA, a specific lot of screws is incorrectly labeled as 5.0mmx18mm when the actual screws are 5.00mmx14mm. If detected during surgery, the issue may cause a minor delay. If not detected and the incorrect screw is used, the issue may increase the risk of earlier mechanical failure, loosening, and need for revision surgery.
Context
GovInfoNow's records show Tornier, Inc. has 12 other recalls on record since Feb. 8, 2018. Other recent recalls of similar products include XTANT Medical Xpress Pedicle Screw System (Feb. 18, 2026), Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025), and APTUS 2.8 TriLock Screw Recall (Jan. 9, 2026).
How to tell if you have this one
Check for the catalog number DWJ318 and lot number AZ4824290 on the screw packaging. The screws are labeled as 5.0mmx18mm but are actually 5.00mmx14mm.
Brand
Tornier
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the catalog number DWJ318 and lot number AZ4824290 on the screw packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1237-2026 (December 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1237-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.