FDA Device recall Z-1257-2024
Embrace Drill Tower, Wedged (25mm)
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of Embrace Drill Tower, Wedged (25mm) by Waldemar Link And Kg Mfg Site, citing the surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1257-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-29 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Waldemar Link And Kg Mfg Site |
| Distribution | US |
Product
Embrace Drill Tower, Wedged (25mm)
Reason
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
Identifiers
| code_info | Item Number: 645-081/62; UDI/DI: 04026575534715; All lots of the LINK Embrace Drill Tower surgical instruments. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1257-2024%22
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