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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 Mix see related information
Date Initiated by Firm December 04, 2014
Date Posted April 17, 2015
Recall Status1 Terminated 3 on May 08, 2017
Recall Number Z-1455-2015
Recall Event ID 70739
510(K)Number K040262  
Product Classification Filler, bone void, calcium compound - Product Code MQV
Product DBX 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
Action MTF notified their customers on 12/4/2014 and 12/8/2014 via phone and letter.
Quantity in Commerce 25 units
Distribution US Nationwide distribution to CA, KY, IL, LA, PA, NC, TN, WV, and Puerto Rico.
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 = MQV and Original Applicant = MUSCULOSKELETAL TRANSPLANT FOUNDATION
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