Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MTF Biologics

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall MTF Biologicssee related information
Date Initiated by FirmMarch 29, 2021
Create DateMay 12, 2021
Recall Status1 Terminated 3 on April 27, 2023
Recall NumberZ-1562-2021
Recall Event ID 87677
Product Classification Filler, bone void, calcium compound - Product Code MQV
ProductAFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007
Code Information Lot/Serial Numbers: 03818070421114 00319018541145 00319022171149 00419019631149 09819009071105 09819036171142 
Recalling Firm/
Manufacturer		 Musculoskeletal Transplant Foundation, Inc.
125 May St Ste 300
Edison NJ 08837-3264
For Additional Information ContactMTF Customer Service Department
800-433-6576
Manufacturer Reason
for Recall		3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
FDA Determined
Cause 2		Packaging change control
ActionMusculoskeletal Transplant Foundation (MTF) issued Voluntary Field Action Notification Letter via FedX on March 29, 2021 to the Distributor. Letter states reason for recall, health risk and action to take: As the distributor. Spineology. we will need you to complete notification to your customers and provide the distribution records. questions. Please feel free to contact me at 732-661-2209. or email MTF RegulatoryAffairs at Regulatory_Customer_Inquiry@mft.org
Quantity in Commerce672 units
DistributionUS Nationwide distribution in the state of MN.
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.
-
-