Device product

1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack

Z-1037-2022

March 22, 2022

Class II

Product summary

Firm: American Contract Systems, Inc.
Event: Event 89868
Status: Ongoing
Classification: Class II
Quantity: 114 packs
Official record key: device-enforcement:Z-1037-2022

Official wording

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

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

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.