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U.S. Department of Health and Human Services

Class 2 Device Recall Grafton DBM AFlex

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  Class 2 Device Recall Grafton DBM AFlex see related information
Date Initiated by Firm August 08, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on December 08, 2011
Recall Number Z-0416-2012
Recall Event ID 60263
510(K)Number K051195  
Product Classification Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
Product Grafton DBM A-Flex; Unit Size 60 mm diam; 1ea
Container: Foil Pouch with Tyvek pouch

Fracture repair, bridge bone gaps or fragments, use with strut grafts
Code Information Catalog Number A42160 Lot #OTSCT08 2972 Exp 4/30/14
Recalling Firm/
Manufacturer		 Osteotech Inc
51 James Way
Eatontown NJ 07724-2272
For Additional Information Contact Mr. Christopher Talbot
732-542-2800
Manufacturer Reason
for Recall		 Aseptic conditions during the production of these products may have been compromised.
FDA Determined
Cause 2		 Material/Component Contamination
Action Osteotech sent a recall letter dated August 8, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all units of the affected product. Customers were asked to contact Osteotech Customer Service at 732-578-6699 within two business days of receiving the letter to acknowledge receipt of the letter and to arrange for a return and exchange or credit for the product. For questions regarding this recall call 732-542-2800.
Quantity in Commerce 18 unts
Distribution Worldwide Distribution
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 = MBP and Original Applicant = OSTEOTECH, INC.
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