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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Titanium Midface Distractor

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 Class 2 Recall
Synthes Titanium Midface Distractor
see related information
Date Posted March 12, 2013
Recall Status1 Open
Recall Number Z-0942-2013
Recall Event ID 64287
Premarket Notification
510(K) Number
K010499 
Product Classification Plate, Bone - Product Code JEY
Product Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Code Information All Lots
Recalling Firm/
Manufacturer
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Manufacturer Reason
for Recall
There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.
FDA Determined
Cause 2
TRAINING: Employee Error
Action The firm initiated their recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter to all consignees. The letter identified the affected product and the problem. Also, the firm requested consignees to examine their inventory for products(s) with the specified part number, remove them from use, and return them to Synthes. Customers were to follow the instructions provided on what to do if they have or do not have any identified affected product. Questions should be directed to 610-719-5450 or FieldAction@synthes.com.
Quantity in Commerce 596
Distribution Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland.
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 = JEY and Original Applicant = SYNTHES (USA)
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