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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 Recall
Synthes 11Hole, 1/3 Tubular Plate DCL Plate with Collar
see related information
Date Posted June 19, 2013
Recall Status1 Open
Recall Number Z-1557-2013
Recall Event ID 64830
Premarket Notification
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, Pennsylvania 19380-3417
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
OTHER/UNDETERMINED: Under Investigation by the 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 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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