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U.S. Department of Health and Human Services

Class 2 Device Recall Musculoskeletal Transplant Foundation

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  Class 2 Device Recall Musculoskeletal Transplant Foundation see related information
Date Initiated by Firm April 21, 2016
Date Posted June 16, 2016
Recall Status1 Terminated 3 on October 18, 2016
Recall Number Z-2004-2016
Recall Event ID 74263
510(K)Number K060161  K042125  
Product Classification Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
Product Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.
Code Information Serial 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 
Recalling Firm/
Musculoskeletal Transplant Foundation, Inc.
125 May St Ste 300
Edison NJ 08837-3264
For Additional Information Contact Ms. Karen Hardwick
Manufacturer Reason
for Recall
AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field.
FDA Determined
Cause 2
Packaging process control
Action Musculoskeletal Transplant Foundation (MTF) sent an Voluntary Field Action Notification Letter dated April 21, 2016, and via telephone to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were notified of the situation with the product and provided instructions on how to handle the product. Questions can be directed to Customer Service Customer at 1-800-433-6576.
Quantity in Commerce 114 units
Distribution nationwide
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 = MUSCULOSKELETAL TRANSPLANT FOUNDATION