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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 2.7mm LCP Ulna Osteotomy System

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  Class 2 Device Recall Synthes 2.7mm LCP Ulna Osteotomy System see related information
Date Initiated by Firm January 07, 2014
Date Posted March 25, 2014
Recall Status1 Terminated 3 on September 10, 2015
Recall Number Z-1274-2014
Recall Event ID 67263
510(K)Number K113364  
Product Classification Plate, fixation, bone - Product Code HRS
Product Drill Template and the Saw Guide for the Ulna Osteotomy System.

Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
Code Information Part Nos. 03.111.900 through 03.111.905, with Lot Nos. 779372, 2638601, 7769386, 2638603, 7836420, 7772531, 2638604, 7836422, 7772538, 2638605, 7836423, 7915554, 7772543, 7772542, 7872775, 8400287, 7772554, 7772555, and 8229040.
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template.
FDA Determined
Cause 2		 Component design/selection
Action A recall notification letter, dated January 7, 2013, was sent to sales consultants and Users.
Quantity in Commerce 343
Distribution Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.
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 = HRS and Original Applicant = SYNTHES (USA) PRODUCTS LLC
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