FDA recall Z-1067-2024

Product

AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)

Reason for recall

Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.

Distribution

Product was distributed to Minnesota.

Key facts

Status

Ongoing

Initiation date

2023-12-22

Report date

2024-02-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Edison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1067-2024