Devices

Device Recall MiniMagnum Knotless Fixation Device

Model / Serial
Lot Number: 1015833
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
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.
Manufacturer
ArthroCare Corporation
1 Event
- Recall of Device Recall MiniMagnum Knotless Fixation Device

Manufacturer

ArthroCare Corporation

Manufacturer Address
ArthroCare Corporation, 680 Vaqueros Ave, Sunnyvale CA 94085-3523
Source
USFDA

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