FDADecember 22, 2023device
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
What to do
FDA enforcement status: Ongoing
Brands named
musculoskeletal transplant foundationmusculoskeletalmusculoskeletal transplant
UPCs
02921115411127
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAProtocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.2026-03-24
- FDASequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)2026-03-20
- FDABostonSight SCLERAL Lens2025-06-10
- FDABostonSight PROSE Lens.2025-06-10
- FDAFoundationOne Companion Diagnostic (F1CDx)2025-04-09
- FDAFoundationOne Companion Diagnostic (F1CDx)2024-06-18
- FDAAFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)2023-12-22
- FDADBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 0381002023-09-22
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