Device product

1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray

Z-1036-2022

March 22, 2022

Class II

Product summary

Firm: American Contract Systems, Inc.
Event: Event 89868
Status: Ongoing
Classification: Class II
Quantity: 72 packs
Official record key: device-enforcement:Z-1036-2022

Official wording

Reason: Product was sterilized with a higher than specification EO concentration.

Code information: 1) ACS Spine Pack - Model LOSP35D, Lot 966221; UDI 00191072154613 2) ACS Lumbar/Back Set Up Tray - Model SALB85AG, Lot 973221; UDI: 00191072127280

Distribution pattern: US Nationwide distribution in the states of IL, MO, NE, and TX.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Product was sterilized with a higher than specification EO concentration.