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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Radial Head Prosthesis System

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  Class 2 Device Recall Synthes Radial Head Prosthesis System see related information
Date Initiated by Firm December 29, 2016
Create Date February 02, 2017
Recall Status1 Open3, Classified
Recall Number Z-1124-2017
Recall Event ID 76182
510(K)Number K112030  
Product Classification Prosthesis, elbow, hemi-, radial, polymer - Product Code KWI
Product Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories

Product Usage:
Intended for primary and revision joint replacement of the radial head.
Code Information Part Numbers:, 03.402.006, 03.402.007, 03.402.008, 03.402.009, 03.402.010, 03.402.018, 03.402.020, 03.402.022, 03.402.024, 03.402.026, 03.402.028, 03.402.106, 03.402.107, 03.402.108, 03.402.109, 03.402.110, 03.402.218, 03.402.220, 03.402.222, 03.402.224, 03.402.226, 03.402.228, 03.402.418, 03.402.420, 03.402.422, 03.402.424, 03.402.426, 03.402.428, 03.402.618, 03.402.620, 03.402.622, 03.402.624, 03.402.626, 03.402.628, 03.402.701, 03.402.710, 03.402.711, 03.402.712, 03.402.716, 03.402.717, 03.402.718, 03.402.719, 03.402.720, 03.402.721, 03.402.722, 03.402.723, 03.402.724, 03.402.725, 03.402.726, 03.402.727, 03.402.728, 03.402.729, 03.402.730, 03.402.731, 03.402.732, 03.402.733, 03.402.734, 03.402.735, 03.402.740, 03.402.741, 03.402.744, 04.402.006S, 04.402.007S, 04.402.008S, 04.402.009S, 04.402.010S, 04.402.026S, 04.402.027S, 04.402.028S, 04.402.029S, 04.402.030S, 09.402.018S, 09.402.020S, 09.402.022S, 09.402.024S, 09.402.026S, 09.402.028S, 09.402.218S, 09.402.220S, 09.402.222S, 09.402.224S, 09.402.226S, 09.402.228S, 09.402.418S, 09.402.420S, 09.402.422S, 09.402.424S, 09.402.426S, 09.402.428S, 09.402.618S, 09.402.620S, 09.402.622S, 09.402.624S, 09.402.626S, 09.402.628S, 60.402.001, 60.402.002, 61.402.001, 01.402.001E.
Recalling Firm/
Manufacturer
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
Manufacturer Reason
for Recall
There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
FDA Determined
Cause 2
Under Investigation by firm
Action An Urgent Notice was mailed to consignees explaining the reason for the recall. Customers were asked to immediately review their inventories for the affected product and complete and return the Verification form that was included with the notification and return any of the affected product that was found.
Quantity in Commerce 50,311 units
Distribution United States Nationwide Distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KWI and Original Applicant = SYNTHES USA, LLC
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