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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 11Hole, 1/3 Tubular Plate DCL Plate with Collar

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  Class 2 Device Recall Synthes 11Hole, 1/3 Tubular Plate DCL Plate with Collar see related information
Date Initiated by Firm February 22, 2013
Date Posted June 19, 2013
Recall Status1 Terminated 3 on May 21, 2015
Recall Number Z-1557-2013
Recall Event ID 64830
510(K)Number K011335  
Product Classification Plate, fixation, bone - Product Code HRS
Product Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
Code Information Part Number 241.000.011, lot number S2004
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm initiated their recall of the product on February 22, 2013 by sending an "Urgent Notice: Medical Device Recall" letter to the firm's sales representatives. The letter requested they examine their inventory, and/or customers inventories for the Part Number and if found, return it to Synthes for appropriate disposition.
Quantity in Commerce 10
Distribution 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 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)
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