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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/Surgical Equipment

Waldemar Link GmbH & Co. KG (Mfg Site): Embrace Drill Tower Recalled Due to Mixed-Up Surgical Descriptions

Agency Publication Date: March 6, 2024
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Summary

Waldemar Link GmbH & Co. KG is recalling 12 units of Embrace Drill Tower surgical instruments (25mm) because the accompanying surgical technique manuals contain incorrect type descriptions. Specifically, the "standard" and "wedged" labels were swapped in the instrument overview section. This affects model numbers 645-081/62 and 645-081/63 which were distributed to healthcare facilities in Alabama and Louisiana. No injuries have been reported, but the error could lead to confusion during surgical procedures.

Risk

The incorrect documentation could cause surgical teams to use the wrong drill tower type during shoulder surgery. Using an incorrectly identified instrument can lead to improper surgical preparation, potential surgical delays, or suboptimal procedure outcomes.

What You Should Do

  1. Check your surgical inventory for the LINK Embrace Drill Tower instruments with Item Number 645-081/62 (Wedged) or 645-081/63 (Standard/Lateral).
  2. Verify the device identity by checking for UDI/DI numbers 04026575534715 (Wedged) or 04026575534722 (Standard/Lateral) on the packaging or device.
  3. Review the surgical technique documentation to ensure the "standard" and "wedged" descriptions are correctly identified despite the error in the overview section.
  4. Contact the manufacturer, Waldemar Link GmbH & Co. KG, or your healthcare provider to receive corrected surgical technique instructions and further guidance.
  5. 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

Corrective action for surgical technique documentation

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

Affected Products

Product: Embrace Drill Tower, Wedged (25mm)
Model / REF:
645-081/62
UPC Codes:
04026575534715
Lot Numbers:
All lots
Product: Embrace Drill Tower, Standard/Lateral (25mm)
Model / REF:
645-081/63
UPC Codes:
04026575534722
Lot Numbers:
All lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93979
Status: Active
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Sold By: Direct distribution to healthcare facilities
Manufactured In: Germany
Units Affected: 2 products (6 units)
Distributed To: Alabama, Louisiana

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.