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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, Inc: Tournier Perform Reversed Lateralized Baseplates Recalled for Assembly Defect

Agency Publication Date: October 13, 2023
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Summary

Tornier, Inc. is recalling one specific lot of its stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplates (Model REF DWJ502) because 30 units were manufactured with incorrect 6mm spacers instead of the required 3mm spacers. This manufacturing error prevents the central screw from properly threading into the baseplate during surgical procedures. These baseplates were distributed in 10 U.S. states including California, Colorado, and Massachusetts.

Risk

The use of an incorrect spacer size prevents the surgical screw from being secured to the baseplate, which could lead to surgical delays, improper implant fixation, or the need for additional medical intervention. No specific injuries have been reported in the recall data.

What You Should Do

  1. Identify if you have the affected medical device by checking the packaging for stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, Model REF DWJ502.
  2. Verify the identifying codes on the product label: look for UDI/DI 10846832062017 and Lot Number 1756123.
  3. If you are a healthcare provider or facility in possession of this specific lot, stop using the affected baseplates immediately and quarantine them to prevent use in surgery.
  4. Contact Tornier, Inc. (Stryker) or your local sales representative for specific instructions regarding the return or replacement of the affected units.
  5. Patients who have recently undergone shoulder surgery involving a Tornier implant and have concerns should contact their orthopedic surgeon or healthcare provider.
  6. For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm
Model / REF:
REF DWJ502
Z-0113-2024
UPC Codes:
10846832062017
Lot Numbers:
1756123

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93051
Status: Active
Manufacturer: Tornier, Inc
Sold By: hospitals; surgical centers; medical distributors
Manufactured In: United States
Units Affected: 30 units
Distributed To: California, Colorado, Illinois, Massachusetts, Minnesota, North Carolina, Oregon, Rhode Island, South Carolina, Tennessee

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.