FDAMarch 29, 2021device
AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
What to do
FDA enforcement status: Terminated
Brands named
musculoskeletal transplant foundationmusculoskeletalmusculoskeletal transplant
UPCs
038180704211140031901854114500319022171149004190196311490981900907110509819036171142
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) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)2023-12-22
- FDAAFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)2023-12-22
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