Device product
Embrace Drill Tower, Wedged (25mm)
Z-1257-2024
Product summary
- Event
- Event 93979
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1257-2024
Official wording
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.
Code information: Item Number: 645-081/62; UDI/DI: 04026575534715; All lots of the LINK Embrace Drill Tower surgical instruments.
Distribution pattern: US Nationwide distribution in the states of AL and LA.
Derived failure modes
-
Unknown
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.