FDA recall Z-2453-2023

Medicrea International · Class II · device

Product

IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar

Reason for recall

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Distribution

US nationwide

Key facts

Status
Ongoing
Initiation date
2023-07-12
Report date
2023-08-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rillieux La Pape, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2453-2023