Date Initiated by Firm | June 09, 2014 |
Date Posted | December 23, 2015 |
Recall Status1 |
Terminated 3 on February 05, 2016 |
Recall Number | Z-0475-2016 |
Recall Event ID |
72695 |
510(K)Number | K132496 |
Product Classification |
Prosthesis, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained - Product Code LZJ
|
Product | 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). |
Code Information |
SN 000242 SN 000244 SN 000246 SN 000247 |
Recalling Firm/ Manufacturer |
Arthrosurface, Inc. 28 Forge Pkwy Franklin MA 02038
|
For Additional Information Contact | Dawn Wilson 508-520-3003 |
Manufacturer Reason for Recall | An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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. |
FDA Determined Cause 2 | Process change control |
Action | 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. |
Quantity in Commerce | 3 units |
Distribution | US Distribution to the states of : PA, WV and CA. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = LZJ
|