Recall Z-1562-2021 ยท MQV Filler, Bone Void, Calcium Compound
Musculoskeletal Transplant Foundation, Inc.
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
| Date | Mar 29, 2021 |
| Status | Terminated |
| Reason | 3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery |
| Root cause | Packaging change control |
| Action | 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 |
| Quantity | 672 units |
| Distribution | US Nationwide distribution in the state of MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.