AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
FDA Recall #Z-1067-2024 — Class II — December 22, 2023
Product Description
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (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
50
Distribution
Product was distributed to Minnesota.
Code Information
UDI-DI: W4184227005T0473 Donor Lots 00322029241137 and 00322039641144
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated