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U.S. Department of Health and Human Services

Class 2 Device Recall MiniMagnum Knotless Fixation Device

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 Class 2 Recall
MiniMagnum Knotless Fixation Device
see related information
Date Posted October 14, 2011
Recall Status1 Terminated on October 24, 2011
Recall Number Z-0049-2012
Recall Event ID 59978
Premarket Notification
510(K) Number
K042584 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Cartridge; Catalog Number: OM-6007; Product is manufactured and distributed by ArthroCare Corporation, Sunnyvale, CA The MiniMagnum Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-Iabral reconstruction, biceps tenodesis and deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
Code Information Lot Number: 1015833
Recalling Firm/
Manufacturer
ArthroCare Corporation
680 Vaqueros Ave
Sunnyvale, California 94085-3523
For Additional Information Contact Bruce Prothro
408-736-0224 Ext. 229
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action 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.
Quantity in Commerce 32 units
Distribution Nationwide distribution: USA including states of: CA, FL, NY, OH and OK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = OPUS MEDICAL, INC.
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