FDAFDA · Food and drugs·Recall number Z-1067-2024
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Published February 21, 2024 · Recall initiated: December 22, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Musculoskeletal Transplant Foundation, Inc.
- Distributor
- Product was distributed to Minnesota.
- Lot
- UDI-DI: W4184227005T0473 Donor Lots 00322029241137 and 00322039641144
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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