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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HRS
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