Recall Z-2454-2023— Medicrea International

Name: FDA recall Z-2454-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-12

Class II · Ongoing

Class II FDA medical device recall by Medicrea International, initiated 2023-07-12. It names one FDA 510(k) clearance: K141187. Product: IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar. Reason: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch..

Recalling firm: Medicrea International
Classification: Class II
Status: Ongoing
Initiated: 2023-07-12
Firm location: Rillieux La Pape, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K141187 — IMPIX ALIF S/AMedicrea International SA·cleared 2015-01-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IMPIX ALIF S/A, REF number B15241415; 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.