Z-1312-06

OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in...

Name: Z-1312-06 OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in...
Creator: ArthroCare Corporation
Published: 2006-06-28
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2006-06-28 / Terminated / root cause: packaging

FDA source

ArthroCare Corporation began a recall of OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in placement of sutures through soft tissue in... on 2006-06-28. The reason FDA records is "The product may lose sterility due to omission of the final 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-1312-06
Status: Terminated
Initiated: 2006-06-28
Posted: 2006-08-02
Terminated: 2007-12-05
Recalling firm: ArthroCare Corporation
Product: OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in placement of sutures through soft tissue in endoscopic and other limited access procedures.
Product code: KOG
Reason for recall: The product may lose sterility due to omission of the final pouch seal.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm has issued notification letters to all customers in the United States on June 29, 2006 via overnight delivery, advising customers to return all product with incomplete or missing seals to Arthocare.
Quantity in commerce: 198 units
Distribution: Nationwide.
Product codes and lots: All products consisting of lot number 110399, Catalog number OM-6006. This catalog number is referred to as the OPUS MiniPlus Implant Set.

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)