FDA Medical Device Recalls (openFDA)
American Contract Systems Inc: ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
- Recall number
- Z-2283-2024
- Recalling firm
- American Contract Systems Inc
- Product
- ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
- Status
- Open, Classified
- Initiated
- 2024-05-15
- Posted
- 2024-07-05
- Terminated
- not on file
- Reason
- Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Root cause
- Under Investigation by firm
- Action
- American Contract Systems issued Urgent Voluntary Recall Letter (FA-2024-018) via email on 5/15/24 to Distributors. Distributors to notify end-users. Letter states reason for recall, health risk and action to take: Immediately discontinue use of the cast padding component (DISCARD ITEM 4927009046-CAST PADDING, 6" Cotton Blend Rayon) included in each kit/tray identified in ATTACHMENT 1. Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. "Add warning labels to all kits/cases impacted: A labeling template is enclosed for printing warning labels which should be affixed to all affected product in inventory. This label should be affixed to each affected kit and case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing labeling. "Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. "Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. "Complete the enclosed Response Form and return as soon as possible. "If credit is requested, please send an email to quality@owens-minor.com.
- Quantity
- 84 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: 00191072197948 LOT#"s: 992241 914241
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJH
- Firm FEI
- 3008492337
- Firm city
- Tiffin
- Firm state
- OH
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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