FDAFDA · Food and drugs·Recall number Z-1066-2024
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (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
- Donor Lot 02921115411127. UDI-DI: W4184227010T0473
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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