Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Product type
Device
Status
Ongoing
Report date
2026-04-01
Distribution
US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
Product quantity
74 units
Initiated by
Voluntary: Firm initiated
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.
Product description
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Code / lot info
Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.