Embrace Drill Tower recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIOngoing
Summary: Waldemar Link GmbH & Co. KG (Mfg Site) is recalling 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.
What is being recalled
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA (states named: Alabama, Arizona, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, North Carolina, Ohio, Oklahoma, Texas, Virginia)
How to tell if yours is affected
Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1651-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 11, 2026 |
| Reported | April 1, 2026 |
| Company | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Company location | Norderstedt, Germany |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 75 units |
More recalls from Waldemar Link GmbH & Co. KG (Mfg Site) · all medical device recalls · recalls from February 2026