Recall archive / FDA device enforcement
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; — FDA record Z-1651-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 11, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
- 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.
- Classification
- Class II
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 75 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1651-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 1, 2026
- Recall initiation date
- Feb 11, 2026
- Center classification date
- Mar 26, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.