Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The co
FDA device recall Z-0475-2016 · posted 2015-12-23 · Terminated
Recall details
- Recalling firm
- Arthrosurface, Inc.
- 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- An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- LZJ
- Quantity affected
- 3 units
- Distribution
- US Distribution to the states of : PA, WV and CA.
- Date initiated
- 2014-06-09
- Date posted
- 2015-12-23
- Date terminated
- 2016-02-05
- Location
- Franklin, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTHROSURFACE TOEMOTION (K132496) | Arthrosurface, Inc. | 2014-02-26 |