Medicrea International: IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar

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: 11 units Lot/code info: a) B15111209, GTIN 03613720193395, Lot Numbers: 19C0772; b) B15111212, GTIN 03613720193401, Lot Numbers: 19C0775, 19G0070; c) B15111409, GTIN 03613720193425, Lot Numbers: 19E0353; d) B15111412, GTIN 03613720193432, Lot Numbers: 19C0788

UPC codes

03613720193395, 03613720193401, 03613720193425, 03613720193432

Source

Official record: FDA (Device enforcement) ↗

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