ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Ca

FDA device recall Z-0049-2012 · posted 2011-10-14 · Terminated

Recall details

Recalling firm

ArthroCare Corporation

Reason for recall

ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant.

Action taken

The firm, ArthroCare Corporation, sent a letter dated May 10, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were asked to immediately return the product; check their inventory, refer to the copy of the Mini Magnum outer label to help identify the product, and if the affected product lot is in their inventory, notify ArthoCare Product Support at (800) 797-6520, press 2 and return the product immediately. The letter also stated, "In addition, if you do not have any product from this lot remaining in your inventory, we request that you contact ArthroCare at the number above, or by e-mail at ra@arthrocare.com, to inform us of the lack of remaining product. This will ensure that you will not be contacted again and that we have accounted for product shipments from this lot." If you have any questions, please call the Chief Regulatory Officer and Senior Vice President, Quality Systems and Assurance at (408) 735-6229.

Root cause

Packaging process control

Status

Terminated

Product code

HWC

Quantity affected

32 units

Distribution

Nationwide distribution: USA including states of: CA, FL, NY, OH and OK.

Date initiated

2011-05-11

Date posted

2011-10-14

Date terminated

2011-10-24

Location

Sunnyvale, CA

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