FDA Enforcement
Class II
Ongoing
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Recall: Z-1067-2024
·
Reported February 21, 2024
Enforcement
- Recall Number
- Z-1067-2024
- 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) Diverted Tube (3/4 Filled), Product Code 227005 (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
UDI-DI: W4184227005T0473 Donor Lots 00322029241137 and 00322039641144
Distribution
Product was distributed to Minnesota.
Quantity
50