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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 Diverted Tube (3/4 Filled), Product Code MQV (bone void filler)
Code Information UDI-DI W4184227005T0473 Donor Lots 00322029241137 and 00322039641144
Recalling Firm/
Manufacturer
Musculoskeletal Transplant Foundation, Inc.
125 May St Ste 300
Edison NJ 08837-3264
For Additional Information Contact MTF Customer Service Department
800-433-6576
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
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