Device product
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Z-1651-2026
Product summary
- Event
- Event 98431
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 75 units
- Official record key
device-enforcement:Z-1651-2026
Official wording
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.
Code information: Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
Distribution pattern: US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
Derived failure modes
-
Unknown
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.