FDA Medical Device Recalls (openFDA)
ArthroCare Corporation: ArthroCare brand OPUS Smartstitch Magnum Wire Suture Cartridge, Catalog Number: OM-8075; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085
- Recall number
- Z-1187-06
- Recalling firm
- ArthroCare Corporation
- Product
- ArthroCare brand OPUS Smartstitch Magnum Wire Suture Cartridge, Catalog Number: OM-8075; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085
- Status
- Terminated
- Initiated
- 2006-06-07
- Posted
- 2006-06-27
- Terminated
- 2006-11-21
- Reason
- Potential loss of product sterility due to breach of pouch seal.
- Root cause
- Packaging process control
- Action
- Notification letters were sent to all customers in the United States on June 7, 2006. All letters were sent via overnight delivery.
- Quantity
- not on file
- Distribution
- Worldwide
- Lot, serial or model codes
- 31144
- 510(k) numbers
- ["K022229"]
- PMA numbers
- not on file
- Product code
- KOG
- Firm FEI
- 3010813691
- Firm city
- Sunnyvale
- Firm state
- CA
- 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