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U.S. Department of Health and Human Services

Class 2 Device Recall OPUS SpeedStitch Suture Cartridge

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  Class 2 Device Recall OPUS SpeedStitch Suture Cartridge see related information
Date Initiated by Firm June 28, 2006
Date Posted August 02, 2006
Recall Status1 Terminated 3 on December 05, 2007
Recall Number Z-1312-06
Recall Event ID 35878
510(K)Number K022229  
Product Classification endoscopic suturing device - Product Code KOG
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.
Code Information All products consisting of lot number 110399, Catalog number OM-6006. This catalog number is referred to as the OPUS MiniPlus Implant Set.
Recalling Firm/
ArthroCare Corporation
680 Vaqueros Ave
Sunnyvale CA 94085-3523
Manufacturer Reason
for Recall
The product may lose sterility due to omission of the final pouch seal.
FDA Determined
Cause 2
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.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KOG and Original Applicant = OPUS MEDICAL, INC.