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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 Device Recall Synthes MultiVector Distractor Body, Part Number 487.931 see related information
Date Initiated by Firm January 11, 2013
Date Posting Updated March 01, 2013
Recall Status1 Terminated 3 on August 31, 2015
Recall Number Z-0903-2013
Recall Event ID 64195
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 PA 19380-3417
For Additional Information Contact customer support
610-719-5000
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
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 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 = DZL and Original Applicant = SYNTHES (USA)
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