Z-0049-2012

ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum...

Name: Z-0049-2012 ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum...
Creator: ArthroCare Corporation
Published: 2011-05-11
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2011-05-11 / Terminated / root cause: packaging

FDA source

ArthroCare Corporation began a recall of ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Cartridge; Catalog Number: OM-6007... on 2011-05-11. The reason FDA records is "ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0049-2012
Status: Terminated
Initiated: 2011-05-11
Posted: 2011-10-14
Terminated: 2011-10-24
Recalling firm: ArthroCare Corporation
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.
Product code: HWC Screw, Fixation, Bone
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.
Root cause tag: packaging
FDA 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 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.
Quantity in commerce: 32 units
Distribution: Nationwide distribution: USA including states of: CA, FL, NY, OH and OK.
Product codes and lots: Lot Number: 1015833

Product code HWC

K042584Class IIOpus Minimagnum Anchor with InserterOpus Medical, Inc. / cleared 2004-12-14

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)