FDA recall Z-2462-2023

Product

IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical

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-2462-2023