Z-1036-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- March 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 packs
Product Description
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Reason for Recall
Product was sterilized with a higher than specification EO concentration.
Distribution Pattern
US Nationwide distribution in the states of IL, MO, NE, and TX.
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