FDA Enforcement
Class II
Ongoing
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Recall: Z-1066-2024
·
Reported February 21, 2024
Enforcement
- Recall Number
- Z-1066-2024
- Event ID
- 93853
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Musculoskeletal Transplant Foundation, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Other
- Report Date
- February 21, 2024
- Initiation Date
- December 22, 2023
- Classification Date
- February 9, 2024
- Address
- 125 May St Ste 300, N/A, Edison, NJ, 08837-3264, United States
Description
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Reason
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Code Info
Donor Lot 02921115411127. UDI-DI: W4184227010T0473
Distribution
Product was distributed to Minnesota.
Quantity
89