Drug recall
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
FDA recall event 93853 · Class II · Musculoskeletal Transplant Foundation, Inc.
Key facts
| Event ID | 93853 |
|---|---|
| Recall numbers | Z-1066-2024, Z-1067-2024 |
| Recalling firm | Musculoskeletal Transplant Foundation, Inc. |
| Product type | Devices |
| Products | AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler), AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues. |
| Initiation date | Dec 22, 2023 |
| Report date | Feb 21, 2024 |
| City | Edison |
| State | NJ |
| Country | United States |
| FEI number | 3001236616 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: