Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
This recall is currently active, issued August 21, 2018. It was issued by Exactech, Inc..
- Company
- Exactech, Inc.
- Recall Initiated
- August 21, 2018
- Recall Number
- Z-0012-2019
- Quantity
- 2 units
- Firm Location
- Gainesville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
In the countries of Australia and France
Lot / Code Info
Serial Numbers: 5214432, 5214445
Root Cause
Under Investigation by firm
Action Taken
The firm disseminated the field safety notice by email on 08/21/2018. The notice requested the following actions: " Immediately cease distribution or use of this product. " Extend the information to their accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in their inventory " Complete and return the attached Recall Acknowledgment Form and Recall Inventory Response Form to Exactech.