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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: Perform Reversed Inserts Recalled for Improperly Assembled Locking Ring

Agency Publication Date: September 27, 2024
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Summary

Tornier, Inc. is recalling 38 units of the Stryker Tornier Perform Humeral System, Reversed Insert (45%) used in shoulder replacement surgeries. The recall was initiated because one specific lot may contain a locking ring that was assembled upside down. This manufacturing defect prevents the humeral insert from securely seating into the stem or spacer during surgery or afterward. Consumers should contact their surgeon or healthcare provider to determine if their implant is part of the affected batch.

Risk

If the locking ring is installed incorrectly, the humeral insert cannot be properly secured. This can lead to the implant components shifting or becoming loose, potentially requiring additional surgical procedures to correct the issue.

What You Should Do

  1. Identify if your implant is part of the affected batch by checking for Batch Lot # 1495AY and Catalog Reference Number (REF) DWP2393.
  2. Check your medical records or contact the surgical facility where your shoulder arthroplasty was performed to verify if the Stryker Tornier Perform Humeral System, Reversed Insert used in your procedure is from Lot 1495AY (GTIN 00846832084494).
  3. If you have already undergone surgery with this device, contact your healthcare provider or orthopedic surgeon to discuss the recall and any necessary follow-up care or monitoring.
  4. If you are a healthcare provider in possession of unused units from Batch Lot # 1495AY, immediately quarantine the products and contact Tornier, Inc. for return instructions.
  5. Contact Tornier, Inc. directly for further information or to report concerns regarding this recall.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393
Model / REF:
REF DWP2393
UPC Codes:
00846832084494
Lot Numbers:
Batch Lot # 1495AY

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95245
Status: Active
Manufacturer: Tornier, Inc
Sold By: Hospitals; Surgical Centers
Manufactured In: United States
Units Affected: 38 units
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.