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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 Foundationsee related information
Date Initiated by FirmApril 21, 2016
Date PostedJune 16, 2016
Recall Status1 Terminated 3 on October 18, 2016
Recall NumberZ-2004-2016
Recall Event ID 74263
510(K)NumberK042125 K060161 
Product Classification Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
ProductMusculoskeletal 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/
Manufacturer		 Musculoskeletal Transplant Foundation, Inc.
125 May St Ste 300
Edison NJ 08837-3264
For Additional Information ContactMs. Karen Hardwick
732-661-0202
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
ActionMusculoskeletal 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 Commerce114 units
Distributionnationwide
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 = MBP
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