Recall Z-1067-2024 ยท MQV Filler, Bone Void, Calcium Compound
Musculoskeletal Transplant Foundation, Inc.
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
| Date | Feb 9, 2024 (initiated Dec 22, 2023) |
| Status | Open, Classified |
| Reason | Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues. |
| Root cause | 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 | 50 |
| Distribution | Product was distributed to Minnesota. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042125 | AFT Musculoskeletal Transplant Foundation, Jul 28, 2005 |