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Recall Observatory FDA recall evidence

Device product

Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

Z-1652-2026

February 11, 2026

Class II

Product summary

Firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Event
Event 98431
Status
Ongoing
Classification
Class II
Quantity
74 units
Official record key
device-enforcement:Z-1652-2026

Official wording

Reason: 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.

Code information: Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;

Distribution pattern: US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.