FDA recall Z-2458-2023

Product

PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; 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-2458-2023