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ArthroCare brand MiniMagnum Knotless Fixation Implant… recallZ-0049-2012 · ArthroCare Corporation · initiated May 11, 2011

Terminated All recalls posted in October 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ArthroCare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-0049-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 11, 2011
Posted by the FDA
Oct 14, 2011
Recalling firm
ArthroCare Corporation
Quantity
32 units
Product code
HWC
FDA submissions
K042584
Distribution
Nationwide distribution: USA including states of: CA, FL, NY, OH and OK.

Product description

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 (models, lots, serial numbers)

Lot Number: 1015833

Other devices under the same FDA submission

1 device cleared under K042584 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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