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.
FDA Recall Z-0049-2012 · Posted 2011-10-14
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Recalling FirmArthroCare Corporation
Recall StatusTerminated
Product CodeHWC
Date Initiated2011-05-11
Date Terminated2011-10-24
Product Quantity32 units
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.
Firm 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 [email protected], 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
Distribution Pattern
Nationwide distribution: USA including states of: CA, FL, NY, OH and OK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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