FDAHealthFebruary 11, 2026
Waldemar Link GmbH & Co. KG (Mfg Site) — Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
⚠️ 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.
Is this relevant to me?
- Geography
- US, AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
- Source agency
- FDA
- Category
- Health
- Published
- February 11, 2026
US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
What's affected?
- Product
- Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
- Lot code
- All
Additional details
Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 74 units.
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