FDAFDA · Food and drugs·Recall number Z-1360-2016
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
Published April 20, 2016 · Recall initiated: January 11, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for a component contained in the Implant System to be non-sterile.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arthrex, Inc.
- Distributor
- Distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI.
- Lot
- Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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