Recall archive / FDA device enforcement
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler) — FDA record Z-1066-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 22, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
- Reason
- Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
- Classification
- Class II
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- Quantity
- 89
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1066-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Donor Lot 02921115411127. UDI-DI: W4184227010T0473 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed to Minnesota.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 21, 2024
- Recall initiation date
- Dec 22, 2023
- Center classification date
- Feb 9, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.