Z-0475-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2015
- Initiation Date
- June 9, 2014
- Termination Date
- February 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
Reason for Recall
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.
Distribution Pattern
US Distribution to the states of : PA, WV and CA.
Code Information
SN 000242 SN 000244 SN 000246 SN 000247