ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.
- Company
- Arthrocare Corporation
- Recall Initiated
- September 30, 2010
- Posted
- April 12, 2011
- Terminated
- August 1, 2011
- Recall Number
- Z-1952-2011
- Quantity
- 170 units
- Firm Location
- Sunnyvale, CA
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.
Distribution
Product was released for distribution in US.
Lot / Code Info
Lot Numbers: W100166, WI00167, W100168
Root Cause
Process control
Action Taken
On 9/30/2010, Arthrocare notified customers via letters explaining the reason for the recall and requesting the product be returned.
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