Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brand
- Tornier
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Tornier
- Product type
- Surgical Screws
- Model numbers
- Lot AZ4824290
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 19, 2025
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Tornier, Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
The Tornier Perform Reversed Perip Screw is a medical device used in orthopedic surgeries. Surgeons rely on these screws for stability and support during procedures.
Why This Is Dangerous
The screws are mislabelled, which can lead to the use of a shorter screw than intended. This mismatch can affect the integrity of surgical repairs.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause inconvenience for healthcare providers who must replace the screws, leading to potential surgical delays.
Practical Guidance
How to identify if yours is affected
- Locate the catalog number on the packaging.
- Verify if the screws are labeled as 5.0mmx18mm.
- Check your inventory for the affected lot number AZ4824290.
Where to find product info
The catalog number and lot number can typically be found on the product packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks after contacting Tornier, Inc.
If the manufacturer is unresponsive
- Document all communication attempts with Tornier, Inc.
- Consider reaching out to the FDA for further guidance.
- Keep a record of your inventory and affected products.
How to prevent similar issues
- Verify product labels before use in surgical settings.
- Purchase from reputable suppliers with clear labeling practices.
- Stay updated on recalls in the medical device industry.
Documentation advice
Keep records of purchase receipts, recall notifications, and any correspondence with Tornier, Inc.
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Product Details
The recall affects catalog number DWJ318 of Tornier’s Perform Reversed Perip Screws. These non-sterile screws were distributed nationwide in the United States.
Key Facts
- Catalog number DWJ318
- Incorrectly labeled screws
- Class II recall
- Risk of surgical delay
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Safety Guide
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