Z-1037-2022 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
- 114 packs
Product Description
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
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 Arthroscopy Kit - Model LMAR15R, Lot 981221; UDI: 00191072152978 2) ACS Knee Kit - Model LWKN46N, Lot 966221; UDI: 00191072150158 3) ACS Hand Pack - Model FHHP63T, Lot 966221, UDI: 00191072149954