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U.S. Department of Health and Human Services

Class 2 Device Recall ArthroCare Opus SpeedLock

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  Class 2 Device Recall ArthroCare Opus SpeedLock see related information
Date Initiated by Firm September 30, 2010
Date Posted April 12, 2011
Recall Status1 Terminated 3 on August 01, 2011
Recall Number Z-1952-2011
Recall Event ID 57830
510(K)Number K090615  
Product Classification Ligament Fixation Device - Product Code MBI
Product ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.
Code Information Lot Numbers: W100166, WI00167, W100168
Recalling Firm/
ArthroCare Corporation
680 Vaqueros Ave
Sunnyvale CA 94085-3523
For Additional Information Contact Bruce Prothro
408-736-0224 Ext. 229
Manufacturer Reason
for Recall
During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.
FDA Determined
Cause 2
Process control
Action On 9/30/2010, Arthrocare notified customers via letters explaining the reason for the recall and requesting the product be returned.
Quantity in Commerce 170 units
Distribution Product was released for distribution in US.
Total Product Life Cycle TPLC Device Report

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 = MBI and Original Applicant = ARTHROCARE CORP.