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Arthrex, Inc. recalls Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for dis
Recalled April 20, 2016 · FDA recall Z-1360-2016 · Arthrex
Hazard
Potential for a component contained in the Implant System to be non-sterile. · FDA Class II
Units
117 devices
Sold at
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.
Description
Potential for a component contained in the Implant System to be non-sterile.
Product
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.
Manufacturer(s)
Arthrex, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →