FDA Enforcement
Class II
Terminated
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).
Recall: Z-0475-2016
·
Reported December 30, 2015
Enforcement
- Recall Number
- Z-0475-2016
- Event ID
- 72695
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arthrosurface, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 30, 2015
- Initiation Date
- June 9, 2014
- Classification Date
- December 23, 2015
- Termination Date
- February 5, 2016
- Address
- 28 Forge Pkwy, N/A, Franklin, MA, 02038, United States
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
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
Code Info
SN 000242 SN 000244 SN 000246 SN 000247
Distribution
US Distribution to the states of : PA, WV and CA.
Quantity
3 units