Arthrex Suture Washer — Class III medical device recall Z-2918-2016
Terminated recall by Arthrex, Inc., reported 2016-10-12, distributed in CA, CO, FL, ID, KY, MA, MN, NY…. The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in th
| Recall number | Z-2918-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrex, Inc., Naples, FL, United States |
| Recall initiated | 2016-08-12 |
| Classified | 2016-09-30 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2019-08-20 |
| Distributed | CA, CO, FL, ID, KY, MA, MN, NY, OR |
| Countries outside the US | TH |
| Quantity | 45 devices |
| UPC / GTIN / UDI-DI | 00888867118607 |
| Lot numbers | 10028617 |
| Model numbers | AR-7000-18T |
Product
Arthrex Suture Washer
Reason for recall
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
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-2918-2016. 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.