FDA Medical Device Recalls (openFDA)
American Contract Systems, Inc.: 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
- Recall number
- Z-1037-2022
- Recalling firm
- American Contract Systems, Inc.
- Product
- 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
- Status
- Open, Classified
- Initiated
- 2022-03-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- Product was sterilized with a higher than specification EO concentration.
- Root cause
- Process control
- Action
- A customer letter dated 04/05/2022 was issued to impacted consignees. The letter instructs the following: 1) Review your inventory and segregate affected product. This product should not be shipped out to customers. 2) Return affected product to 2610 NE Industrial Drive, Suite 220, Kansas City, MO 64120. 3) If product was already further distributed, ensure that all downstream customers are properly notified of the recall and maintain records of effectiveness. A Field Action Response Form should be completed and returned to suzanne.thomas@hyh.com, even if you do not have product inventory.
- Quantity
- 114 packs
- Distribution
- US Nationwide distribution in the states of IL, MO, NE, and TX.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJH
- Firm FEI
- 3003419114
- Firm city
- Kansas City
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28