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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

Waldemar Link GmbH & Co. KG (Mfg Site): BiMobile Dual Mobility System Liner Recalled Due to Mislabeled Packaging

Agency Publication Date: February 29, 2024
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Summary

Waldemar Link GmbH & Co. KG is recalling the LINK BiMobile Dual Mobility System E-Poly Liner because the packaging incorrectly identifies the insert as type 'F' when it is actually type 'G'. This surgical implant is used in patients with hip joint fractures or mobility-limiting diseases to restore function. Because the label does not match the product inside, surgical teams may not have the correct size or type ready during an operation, which could result in a delay in surgery while a correct replacement is located.

Risk

The mismatch between the outer packaging and the actual surgical insert can cause unexpected delays during a hip replacement or repair procedure. These delays while a patient is under anesthesia increase the risk of surgical complications or the need for additional medical intervention.

What You Should Do

  1. Identify if you have the affected LINK BiMobile Dual Mobility System E-Poly Liner by checking the packaging for Item Number 184-280/12 and UDI-DI: 04026575230747.
  2. Check the specific lot numbers on the packaging; only lot numbers 2334253 and 2325426 are included in this recall.
  3. Surgical facilities should immediately examine their inventory and quarantine any units matching these lot numbers to ensure they are not used in upcoming procedures.
  4. Contact your healthcare provider or Waldemar Link GmbH & Co. KG directly to discuss the next steps for returning affected products and obtaining a replacement.
  5. Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for replacement or further instructions

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

Affected Products

Product: LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell
Model / REF:
184-280/12
UPC Codes:
04026575230747
Lot Numbers:
2334253
2325426

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93944
Status: Active
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Sold By: Authorized medical distributors
Manufactured In: Germany
Distributed To: Illinois, Indiana, Florida, Washington

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.