Class III — Arthrex, Inc.
| Recalling firm | ARTHREX, INC. |
|---|---|
| Registered facility | View this company's 20 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package. |
| Product | Arthrex Suture Washer |
| Quantity | 45 devices |
| Distribution | OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand. |
| Initiated | 2016-08-12 |
| Classified | 2016-09-30 |
| Terminated | 2019-08-20 |
| Recall number | Z-2918-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Arthrex, Inc. (Z-2918-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75050/
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