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.
Reported: April 20, 2016 Initiated: January 11, 2016 #Z-1360-2016
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.
Reason for Recall
Potential for a component contained in the Implant System to be non-sterile.
Details
- Recalling Firm
- Arthrex, Inc.
- Units Affected
- 117 devices
- Distribution
- 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.
- Location
- Naples, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Arthrex, Inc.. Units affected: 117 devices.
Why was this product recalled? ▼
Potential for a component contained in the Implant System to be non-sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2016. Severity: Moderate. Recall number: Z-1360-2016.
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