Device 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.
Z-1360-2016
Product summary
- Firm
- Arthrex, Inc.
- Event
- Event 73579
- Status
- Terminated
- Classification
- Class II
- Quantity
- 117 devices
- Official record key
device-enforcement:Z-1360-2016
Official wording
Reason: Potential for a component contained in the Implant System to be non-sterile.
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.
Derived failure modes
-
Unknown
Potential for a component contained in the Implant System to be non-sterile.