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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

Embrace Shoulder Instruments Drill Towers Recalled for Mismatched Article Numbers

Agency Publication Date: March 27, 2026
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Summary

Waldemar Link GmbH & Co. KG is recalling 149 units of Embrace Shoulder Instruments Drill Towers because the surgical technique overview contains incorrect article numbers. While the individual surgical steps described are correct, the overview lists mismatched identifying numbers for the Wedged and Standard/Lateral drill towers. This recall affects various models distributed across 14 U.S. states.

Risk

Mismatched article numbers in surgical documentation could lead to the selection or use of an incorrect instrument during surgery. While the specific procedural steps remain accurate, any confusion regarding instrument identification could potentially delay a procedure or result in improper surgical technique.

What You Should Do

  1. Identify if you have the affected instruments by checking for Item Numbers 645-081/62 or 645-081/63 on your device labels or surgical kits.
  2. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  3. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Embrace Drill Tower, Wedged (25mm)
Variants: 25mm, Wedged
Model / REF:
645-081/62
Lot Numbers:
All Lots
UDI:
04026575534715

Recall #: Z-1651-2026; Quantity: 75 units

Product: Embrace Drill Tower, Standard/Lateral (25mm)
Variants: 25mm, Standard/Lateral
Model / REF:
645-081/63
Lot Numbers:
All Lots
UDI:
04026575534715

Recall #: Z-1652-2026; Quantity: 74 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98431
Status: Active
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Sold By: Authorized surgical distributors
Manufactured In: Germany
Units Affected: 2 products (75 units; 74 units)
Distributed To: Alabama, Arizona, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, North Carolina, Ohio, Oklahoma, Texas, Virginia

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.