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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Variable Angle LCP Dorsal Distal Radius System

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 Class 2 Recall
Synthes Variable Angle LCP Dorsal Distal Radius System
see related information
Date Posted March 15, 2013
Recall Status1 Open
Recall Number Z-0956-2013
Recall Event ID 64194
Premarket Notification
510(K) Number
K102694 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion.
Code Information Lot number 7965181
Recalling Firm/
Manufacturer
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Manufacturer Reason
for Recall
It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree).
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action The firm initiated their recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter to consignees. The letter identified the affected product and the issue. Synthes requested customers to examine their inventory for the affected product, remove them from use, and return them to Synthes. Additionally, customers were to follow the steps provided in the event that they did or did not have any affected product on hand. Questions should be directed to 610-719-5450 or FieldAction@synthes.com.
Quantity in Commerce 4
Distribution Distributed in the states of IN, OH, PA, and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = SYNTHES (USA)
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