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U.S. Department of Health and Human Services

Class 2 Device Recall Musculoskeletal Transplant Foundation DBX Demineralized Bone Matrix Mix

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 Class 2 Device Recall Musculoskeletal Transplant Foundation DBX Demineralized Bone Matrix Mixsee related information
Date Initiated by FirmDecember 04, 2014
Date PostedApril 17, 2015
Recall Status1 Terminated 3 on May 08, 2017
Recall NumberZ-1455-2015
Recall Event ID 70739
510(K)NumberK040262 
Product Classification Filler, bone void, calcium compound - Product Code MQV
ProductDBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
Code Information 064130067910690008; 064130067910690009; 064130067910690004; 064130067910690023; 064130067910690024 064130067910690005; 064130067910690015; 064130067910690016; 064130067910690018; 064130067910690020; 064130067910690007; 064130067910690013; 064130067910690028; 064130067910690029; 064130067910690030; 064130067910690010; 064130067910690006; 064130067910690011; 064130067910690012; 064130067910690019; 064130067910690021; 064130067910690014; 064130067910690017; 064130067910690001; 064130067910690022
Recalling Firm/
Manufacturer		 Musculoskeletal Transplant Foundation, Inc.
125 May St Ste 300
Edison NJ 08837-3264
For Additional Information Contact
800-433-6576
Manufacturer Reason
for Recall		The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.
FDA Determined
Cause 2		Packaging process control
ActionMTF notified their customers on 12/4/2014 and 12/8/2014 via phone and letter.
Quantity in Commerce25 units
DistributionUS Nationwide distribution to CA, KY, IL, LA, PA, NC, TN, WV, and Puerto Rico.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MQV
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