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U.S. Department of Health and Human Services

Class 2 Device Recall LINK Embrace Shoulder System

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 Class 2 Device Recall LINK Embrace Shoulder Systemsee related information
Date Initiated by FirmFebruary 11, 2026
Date PostedMarch 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1651-2026
Recall Event ID 98431
Product Classification Bit, drill - Product Code HTW
ProductEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Code Information Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
FEI Number 3003386935
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Ost Str. 4-10
Norderstedt Germany
For Additional Information ContactJennifer Lubrecht
862-477-0370
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 complaints@linkbio.com for any questions.
Quantity in Commerce75 units
DistributionUS distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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