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).
This recall has been terminated (originally issued December 23, 2015).
- Company
- Arthrosurface, Inc.
- Recall Initiated
- June 9, 2014
- Posted
- December 23, 2015
- Terminated
- February 5, 2016
- Recall Number
- Z-0475-2016
- Quantity
- 3 units
- Firm Location
- Franklin, MA
- Official Source
- View on FDA website ↗
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An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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
US Distribution to the states of : PA, WV and CA.
Lot / Code Info
SN 000242 SN 000244 SN 000246 SN 000247
Root Cause
Process change control
Action Taken
The distributors were verbally notified, and replacement Rev F Hex Drivers sent to the locations of the kits. The kits had been moved in preparation for upcoming surgeries, but the Drivers were replaced prior to any additional surgery taking place. No affected product remains in the field. For further questions, please call (508) 520-3003.
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