Recall Z-0012-2019
Exactech, Inc. · initiated August 21, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Codes / lots: Serial Numbers: 5214432, 5214445
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.
FDA-determined 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.
Details
- Recall number
- Z-0012-2019
- Initiated
- August 21, 2018
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Quantity
- 2 units
- Distribution
- In the countries of Australia and France
- Recalling firm
- Exactech, Inc., Gainesville, FL