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U.S. Department of Health and Human Services

Class 2 Device Recall LINK Embrace Shoulder System, Drill Tower instrument

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  Class 2 Device Recall LINK Embrace Shoulder System, Drill Tower instrument see related information
Date Initiated by Firm January 29, 2024
Date Posted March 06, 2024
Recall Status1 Open3, Classified
Recall Number Z-1257-2024
Recall Event ID 93979
Product Classification Bit, drill - Product Code HTW
Product Embrace Drill Tower, Wedged (25mm)
Code Information Item Number: 645-081/62; UDI/DI: 04026575534715; All lots of the LINK Embrace Drill Tower surgical instruments.
Recalling Firm/
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
Manufacturer Reason
for Recall
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
FDA Determined
Cause 2
Under Investigation by firm
Action LinkBio Corp issued Urgent: Medical Device Correction letter via email on 2/8/24 to Distributors. Letter states reason for recall, health risk and action to take: Please take note of the correction of the Surgical Techniques 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 Commerce 6 units
Distribution US Nationwide distribution in the states of AL and LA.
Total Product Life Cycle TPLC 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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