Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
FDA Recall Z-1652-2026 · Posted 2026-03-27
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Recalling FirmWaldemar Link GmbH & Co. KG (Mfg Site)
Recall StatusOpen, Classified
Product CodeHTW
Date Initiated2026-02-11
Product Quantity74 units
Reason for Recall
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
Firm Action
On February 11, 2026 "URGENT: MEDICAL DEVICE CORRECTION" letters were emailed to customers. Actions to be taken: Please take note of the correction of the Surgical Technique noted in section 2. No product return is required.
Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to follow the updated surgical technique.
Please contact LinkBio at 973-625-1333 or [email protected] for any questions.
Root Cause
Under Investigation by firm
Distribution Pattern
US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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