FDA Device recall Z-1036-2022
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
- FDA Device
- Class II
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray by American Contract Systems, citing product was sterilized with a higher than specification EO concentration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1036-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-22 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Reason
Product was sterilized with a higher than specification EO concentration.
Identifiers
| code_info | 1) ACS Spine Pack - Model LOSP35D, Lot 966221; UDI 00191072154613 2) ACS Lumbar/Back Set Up Tray - Model SALB85AG, Lot 973221; UDI: 00191072127280 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1036-2022%22
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