Recall Z-2457-2023— Medicrea International

Name: FDA recall Z-2457-2023
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: K083798. Product: IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; 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

K083798 — IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBFMedicrea Technologies·cleared 2010-05-19

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 TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; 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.