FDA Device recall Z-1651-2026
Embrace Drill Tower, Wedged (25mm)
- FDA Device
- Class II
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class II recall of Embrace Drill Tower, Wedged (25mm) by Waldemar Link And Kg Mfg Site, citing 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1651-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-11 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Waldemar Link And Kg Mfg Site |
| Distribution | AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA |
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.
Identifiers
| code_info | Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1651-2026%22
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