Device product
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Z-0012-2019
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 80996
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0012-2019
Official wording
Reason: The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.
Code information: Serial Numbers: 5214432, 5214445
Distribution pattern: In the countries of Australia and France
Derived failure modes
-
Unknown
The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.