FDAAugust 15, 2019device
QuickGraft¿ Model # 430PST
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.
What to do
FDA enforcement status: Terminated
Brands named
musculoskeletal transplant foundationmusculoskeletalmusculoskeletal transplant
UPCs
003190049210750031900492107300319007681048003190144110850061805223105903319006511040033190091910290331901923107203519018121056
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 PROSE Lens.2025-06-10
- FDABostonSight SCLERAL Lens2025-06-10
- 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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