FDA Device recall Z-1067-2024
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
- FDA Device
- Class II
- ongoing
- Published 2024-02-21
On 2024-02-21 the FDA classified a Class II recall of AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler) by Musculoskeletal Transplant Foundation, citing filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1067-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-22 |
| Published | 2024-02-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Musculoskeletal Transplant Foundation |
| Distribution | MN |
Product
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Reason
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Identifiers
| code_info | UDI-DI: W4184227005T0473 Donor Lots 00322029241137 and 00322039641144 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1067-2024%22
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