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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes MultiVector Distractor Body, Part Number 487.931

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 Class 2 Recall
Synthes MultiVector Distractor Body, Part Number 487.931
see related information
Date Posted March 01, 2013
Recall Status1 Open
Recall Number Z-0903-2013
Recall Event ID 64195
Premarket Notification
510(K) Number
K010690 
Product Classification Screw, Fixation, Intraosseous - Product Code DZL
Product Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Code Information Part number 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090.
Recalling Firm/
Manufacturer
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Manufacturer Reason
for Recall
It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm, Synthes (USA) sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firmat 610-719-5450 for questions regarding this notice.
Quantity in Commerce 2
Distribution Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
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 = DZL and Original Applicant = SYNTHES (USA)
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