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U.S. Department of Health and Human Services

Class 2 Device Recall AFT Diverted Tube

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  Class 2 Device Recall AFT Diverted Tube see related information
Date Initiated by Firm December 22, 2023
Date Posted February 09, 2024
Recall Status1 Open3, Classified
Recall Number Z-1067-2024
Recall Event ID 93853
510(K)Number K042125  
Product Classification Filler, bone void, calcium compound - Product Code MQV
Product AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Code Information UDI-DI: W4184227005T0473 Donor Lots 00322029241137 and 00322039641144
Recalling Firm/
Musculoskeletal Transplant Foundation, Inc.
125 May St Ste 300
Edison NJ 08837-3264
For Additional Information Contact MTF Customer Service Department
Manufacturer Reason
for Recall
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm notified their distributor of the issue during a meeting on December 22, 2023. A notification letter was also issued to the distributor. If the device/tissue was transplanted, no further action is warranted. However, if the device/tissue is still available in the customer's inventory, the unit shall be returned to Spineology, the distributor. Should you have any questions, please contact the firm at 732-661-2209, or email MTF Regulatory Affairs at Regulatory_Customer_Inquiry@mtf.org.
Quantity in Commerce 50
Distribution Product was distributed to Minnesota.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = MUSCULOSKELETAL TRANSPLANT FOUNDATION