AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
FDA Recall #Z-1066-2024 — Class II — December 22, 2023
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.
Recalling Firm
Musculoskeletal Transplant Foundation, Inc. — Edison, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
89
Distribution
Product was distributed to Minnesota.
Code Information
Donor Lot 02921115411127. UDI-DI: W4184227010T0473
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated