Arthrex, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1360-2016)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2016.
Data Source: FDA.
Product Description:
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.
Product Classification:
Class II
Date Initiated: January 11, 2016
Date Posted: April 20, 2016
Recall Number: Z-1360-2016
Event ID: 73579
Reason for Recall:
Potential for a component contained in the Implant System to be non-sterile.
Status: Terminated
Product Quantity: 117 devices
Code Information:
Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.
Distribution Pattern:
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.
Voluntary or Mandated:
Voluntary: Firm initiated