American Contract Systems, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1036-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: March 22, 2022
Date Posted: May 18, 2022
Recall Number: Z-1036-2022
Event ID: 89868
Reason for Recall:

Product was sterilized with a higher than specification EO concentration.

Status: Ongoing
Product Quantity: 72 packs
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.

Voluntary or Mandated:

Voluntary: Firm initiated