Home / Recalls / Medicrea International / Z-2461-2023

Z-2461-2023 Class II Ongoing

Recalled by Medicrea International — Rillieux La Pape, N/A

Recall Details

Product Type
Devices
Report Date
August 30, 2023
Initiation Date
July 12, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
0 (US)

Product Description

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 Pattern

US nationwide

Code Information

a) B15328071S, GTIN 03613720195535, Lot Numbers: 19I0696, 20A0759; b) B15328073S, GTIN 03613720195573, Lot Numbers: 20B0747; c) B15328074S, GTIN 03613720195597, Lot Numbers: 19I0698; d) B15334072S, GTIN 03613720195832, Lot Numbers: 19I0557, 20F0185; e) B15334073S, GTIN 03613720195856, Lot Numbers: 19J0947; f) B15334074S, GTIN 03613720195870, Lot Numbers: 19E0502, 19J0091, 20F0184

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  • Z-1118-2025 Class II — UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 U (December 3, 2024)
  • Z-2457-2023 Class II — IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d (July 12, 2023)
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  • Z-2454-2023 Class II — IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar (July 12, 2023)
  • Z-2458-2023 Class II — PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B (July 12, 2023)
  • Z-2456-2023 Class II — IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) (July 12, 2023)
  • Z-2460-2023 Class II — IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B2 (July 12, 2023)