Arthrex Deltoid Ligament Reconstruction Implant System — Class II medical device recall Z-1360-2016
Terminated recall by Arthrex, Inc., reported 2016-04-20, distributed in AR, AZ, CA, CO, FL, IL, IN, KS…. Potential for a component contained in the Implant System to be non-sterile.
| Recall number | Z-1360-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrex, Inc., Naples, FL, United States |
| Recall initiated | 2016-01-11 |
| Classified | 2016-04-08 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2019-07-24 |
| Distributed | AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, WI |
| Quantity | 117 devices |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00888867131446 |
| Lot numbers | 10020303 |
| Model numbers | AR-8918CP |
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 for recall
Potential for a component contained in the Implant System to be non-sterile.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1360-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.