Recall Z-1360-2016 ยท HRS Plate, Fixation, Bone
Arthrex, Inc.
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.
| Date | Jan 11, 2016 |
| Status | Terminated |
| Reason | Potential for a component contained in the Implant System to be non-sterile. |
| Root cause | Other |
| Action | On 01/22/2016, all distributors and end user facilities were sent an Urgent Medical Device Voluntary Recall letter by Arthrex, Inc. The firm is voluntarily recalling and replacing the referenced device. Immediately discontinue distributing and use of the indicated product and return to Arthrex. Additionally the Recall Acknowledgement of Receipt card should be completed and returned. Contact Customer Service at 800-934-4404 for replacement and return information. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031666 | ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS Arthrex, Inc., Nov 18, 2003 |