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.
FDA Recall Z-1312-06 · Posted 2006-08-02
Advertisement
Recalling FirmArthroCare Corporation
Recall StatusTerminated
Product CodeKOG
Date Initiated2006-06-28
Date Terminated2007-12-05
Product Quantity198 units
Reason for Recall
The product may lose sterility due to omission of the final pouch seal.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Nationwide.
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.
Advertisement