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

Hazard

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

Details from the source

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: US nationwide Quantity: 0 (US) Lot/code info: 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

UPC codes

03613720195535, 03613720195573, 03613720195597, 03613720195832, 03613720195856, 03613720195870

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.