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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 FirmJune 09, 2014
Date PostedDecember 23, 2015
Recall Status1 Terminated 3 on February 05, 2016
Recall NumberZ-0475-2016
Recall Event ID 72695
510(K)NumberK132496 
Product Classification Prosthesis, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained - Product Code LZJ
ProductTotal 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 ContactDawn 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An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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
ActionThe 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 Commerce3 units
DistributionUS Distribution to the states of : PA, WV and CA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LZJ
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