Recall Z-0049-2012 ยท HWC Screw, Fixation, Bone
ArthroCare Corporation
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, SLA
| Date | Oct 14, 2011 (initiated May 11, 2011) |
| Status | Terminated |
| Reason | ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant. |
| Root cause | 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 |
| Quantity | 32 units |
| Distribution | Nationwide distribution: USA including states of: CA, FL, NY, OH and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042584 | OPUS MINIMAGNUM ANCHOR WITH INSERTER Opus Medical, Inc., Dec 14, 2004 |