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U.S. Department of Health and Human Services

Class 2 Device Recall Arthrosurface ToeMotion"

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  Class 2 Device Recall Arthrosurface ToeMotion" see related information
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for Recall		 An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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 and Original Applicant = ARTHROSURFACE, INC.
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