XTANT Medical Holdings, Inc: Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X

Hazard

Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

Details from the source

Reason for recall: Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date. Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia. Quantity: 14 units Lot/code info: Model X080-382819-08PC-STR: UDI-DI M697X08038281908PCSTR1, Lot Number 054961; Model Number X080-423011-08PC-STR: UDI-DI: M697X08042301108PCSTR1, Lot Number 053028

Source

Official record: FDA (Device enforcement) ↗

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