Date Initiated by Firm | September 22, 2023 |
Date Posted | November 17, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0323-2024 |
Recall Event ID |
93296 |
Product Classification |
Filler, bone void, calcium compound - Product Code MQV
|
Product | DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
Model Number: 038100 |
Code Information |
GUID: W4184038100T0473
Serial #s:
002220854711400006
002220854711400056
002220854711400003
002220854711400008
002220854711400009
002220854711400001
002220854711400002
002220854711400010
002220854711400011
002220854711400012
002220854711400013
002220854711400014
002220854711400004
002220854711400005
002220854711400007
Exp.Date: June 20, 2025 |
Recalling Firm/ Manufacturer |
Musculoskeletal Transplant Foundation, Inc. 125 May St Ste 300 Edison NJ 08837-3264
|
For Additional Information Contact | SAME 732-661-2209 |
Manufacturer Reason for Recall | Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery. |
FDA Determined Cause 2 | Labeling Change Control |
Action | MTF Biologicals issued Voluntary Market Withdrawal Notification Letter via customer service scripts on 9/22/23 and provided written notification via letter and/or Email on 10/3/23 to customers . Letter states reason for recall, health risk and action to take:
If the tissue is still available in your inventory, we request you return the tissue to us. We will send a replacement if required.
Should you have any questions, please contact Customer Service at 1-800-433-6576, or please feel free to contact me at 732-661-2209, or email MTF Regulatory Affairs at Regulatory_Customer_Inquiry@mtf.org.
|
Quantity in Commerce | 18 units |
Distribution | US Nationwide distribution in the states of PA, TX, WA. |
Total Product Life Cycle | TPLC Device Report |
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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.
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