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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Tornier Perform Reversed Peripheral Screws Recalled for Incorrect Labeling

Agency Publication Date: February 2, 2026
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Summary

Tornier, Inc. is recalling 427 Tornier Perform Reversed Peripheral Screws because they are labeled with the wrong size. While the packaging states the screws are 18mm long, they are actually only 14mm long. This labeling error may be noticed during surgery, causing a delay, or the wrong size screw could be implanted in a patient's shoulder.

Risk

If the shorter 14mm screw is mistakenly used when an 18mm screw is required, the implant may not be securely fastened. This increases the risk of the hardware loosening, mechanical failure of the shoulder replacement, and the need for a second painful revision surgery.

What You Should Do

  1. Stop using the recalled Tornier Perform Reversed Peripheral Screws immediately.
  2. Check your surgical inventory for catalog number DWJ318 with Lot AZ4824290.
  3. Identify the affected products by the '5.0MMX18MM' label on the non-sterile packaging which contains 5.00mmx14mm screws.
  4. Contact Tornier, Inc. or your local distributor to arrange for the return, replacement, or correction of the affected screws.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions or wish to report a problem.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE
Model / REF:
DWJ318
Lot Numbers:
AZ4824290

Recalled because 14mm screws were placed in packaging labeled as 18mm.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98123
Status: Active
Manufacturer: Tornier, Inc
Sold By: Medical distributors; Hospitals
Manufactured In: United States
Units Affected: 427
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.