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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

Howmedica Osteonics Corp.: Triathlon Universal TS Baseplate Recalled for Surgical Locking Tab Defect

Agency Publication Date: October 7, 2024
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Summary

Howmedica Osteonics Corp. (Stryker) is recalling 16 units of the Triathlon Universal TS Baseplate Size 2, a surgical implant used in total knee replacement surgeries. The recall was initiated because the front locking tabs on the device were manufactured incorrectly and may not properly connect to the knee insert during surgery. This defect was identified during manufacturing, and the affected devices were distributed across seven states: Arizona, Florida, North Carolina, Ohio, Pennsylvania, Tennessee, and Wisconsin. Consumers should contact their healthcare provider if they have recently undergone a knee replacement involving this system.

Risk

The incorrect size of the locking tabs can prevent the baseplate from securely holding the tibial insert in place. If the components do not lock correctly during surgery, it could lead to joint instability, device failure, or the need for a follow-up revision surgery to correct the issue.

What You Should Do

  1. Check your surgical facility's inventory for Triathlon Universal TS Baseplate Size 2 with Catalog Number 5521-B-200 and UDI-DI 07613327026306.
  2. Verify if the device belongs to affected lot numbers LZX4LB or OLH7VA.
  3. Immediately quarantine any matching devices and discontinue their use in all surgical procedures.
  4. Complete and sign the 'Urgent Medical Device Recall Business Reply Form' and email it to strykerortho8441@sedgwick.com or fax it to (800) 871-7417 within 5 days.
  5. Contact your local Stryker Sales Office or Sales Representative at (201) 831-5000 to arrange for product replacement and return instructions.
  6. Return the affected devices to Stryker Orthopaedics/PFA Product Returns, Attn: Distribution Inventory Team, 325 Corporate Drive, Dock M-East, Mahwah, NJ 07430.
  7. Contact the FDA hotline at 1-888-463-6332 for additional questions regarding medical device safety.

Your Remedy Options

You have 2 options:

๐Ÿ”„Option 1: Free Replacement

Product replacement and return of affected units.

How to: Quarantine the device, complete the business reply form, and contact your local Sales Representative for replacement inventory.
๐Ÿ“‹Option 2: Other Action

Medical Device Consultation

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

Affected Products

Product: Triathlon Universal TS Baseplate Size 2
Model / REF:
Catalog Number: 5521-B-200
Recall #: Z-0023-2025
UPC Codes:
07613327026306
Lot Numbers:
LZX4LB
OLH7VA

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95315
Status: Active
Manufacturer: Howmedica Osteonics Corp.
Sold By: Stryker Branch/Agency; Medical Facilities
Manufactured In: United States
Units Affected: 16 units
Distributed To: Arizona, Florida, North Carolina, Ohio, Pennsylvania, Tennessee, Wisconsin

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.