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Terminated

ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.

FDA Recall Z-1952-2011 · Posted 2011-04-12

Recalling FirmArthroCare Corporation
Recall StatusTerminated
Product CodeMBI
Date Initiated2010-09-30
Date Terminated2011-08-01
Product Quantity170 units

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.

Firm Action

On 9/30/2010, Arthrocare notified customers via letters explaining the reason for the recall and requesting the product be returned.

Root Cause

Process control

Distribution Pattern

Product was released for distribution in US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090615OPUS SPEEDLOCK KNOTLESS FIXATION DEVICEArthrocare Corp. · 2009-06-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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