FDA-Device2023-08-30Class II
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
Medicrea International
Hazard
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Sold states
US nationwide
Affected count
963 units
Manufactured in
Vancia, Vancia, Rillieux La Pape, N/A, France
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2458-2023Don't want to check this manually?
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