FDA recall Z-2461-2023

Product

IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; 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-2461-2023