Z-1066-2024 Class II Ongoing
FDA device recall Z-1066-2024 was initiated by Musculoskeletal Transplant Foundation, Inc. on December 22, 2023 and is designated Class II. Reason for recall: Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues. The recall status is ongoing. Affected quantity: 89.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2024
- Initiation Date
- December 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89
Product Description
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Reason for Recall
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Distribution Pattern
Product was distributed to Minnesota.
Code Information
Donor Lot 02921115411127. UDI-DI: W4184227010T0473