ArthroCare brand OPUS Smartstitch Magnum Wire Suture Cartridge, Catalog Number: OM-8075; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085
FDA Recall Z-1187-06 · Posted 2006-06-27
Recalling FirmArthroCare Corporation
Recall StatusTerminated
Product CodeKOG
Date Initiated2006-06-07
Date Terminated2006-11-21
Reason for Recall
Potential loss of product sterility due to breach of pouch seal.
Firm Action
Notification letters were sent to all customers in the United States on June 7, 2006. All letters were sent via overnight delivery.
Root Cause
Packaging process control
Distribution Pattern
Worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.