FDA Device recall Z-1360-2016
Arthrex Deltoid Ligament Reconstruction Implant System
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of Arthrex Deltoid Ligament Reconstruction Implant System by Arthrex, citing potential for a component contained in the Implant System to be non-sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1360-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arthrex |
| Distribution | AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, WI |
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.
Reason
Potential for a component contained in the Implant System to be non-sterile.
Identifiers
| code_info | Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1360-2016%22
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