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Recall Observatory FDA recall evidence

Device product

IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical

Z-2461-2023

July 12, 2023

Class II

Product summary

Firm
Medicrea International
Event
Event 92738
Status
Ongoing
Classification
Class II
Quantity
0 (US)
Official record key
device-enforcement:Z-2461-2023

Official wording

Reason: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

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

Distribution pattern: US nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.