AFT 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
This recall has been terminated (originally issued March 29, 2021).
- Recall Initiated
- March 29, 2021
- Terminated
- April 27, 2023
- Recall Number
- Z-1562-2021
- Quantity
- 672 units
- Firm Location
- Edison, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
Distribution
US Nationwide distribution in the state of MN.
Lot / Code Info
Lot/Serial Numbers: 03818070421114 00319018541145 00319022171149 00419019631149 09819009071105 09819036171142
Root Cause
Packaging change control
Action Taken
Musculoskeletal 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