Z-1186-06

ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is distributed by...

Name: Z-1186-06 ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is distributed by...
Creator: ArthroCare Corporation
Published: 2006-06-07
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2006-06-07 / Terminated / root cause: packaging

FDA source

ArthroCare Corporation began a recall of ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA... on 2006-06-07. The reason FDA records is "Potential loss of product sterility due to breach of pouch seal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1186-06
Status: Terminated
Initiated: 2006-06-07
Posted: 2006-06-27
Terminated: 2006-11-21
Recalling firm: ArthroCare Corporation
Product: ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085
Product code: KOG
Reason for recall: Potential loss of product sterility due to breach of pouch seal.
Root cause tag: packaging
FDA 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.
Distribution: Worldwide
Product codes and lots: 21134

Product code KOG

K022229Class IISmartstitch Suture Device, Model Om-8500Opus Medical, Inc. / cleared 2002-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)