AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
This recall is currently active, issued February 9, 2024. It was issued by Musculoskeletal Transplant Foundation, Inc..
- Recall Initiated
- December 22, 2023
- Posted
- February 9, 2024
- Recall Number
- Z-1066-2024
- Quantity
- 89
- Firm Location
- Edison, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Distribution
Product was distributed to Minnesota.
Lot / Code Info
Donor Lot 02921115411127. UDI-DI: W4184227010T0473
Root Cause
Nonconforming Material/Component
Action Taken
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.