Class II — 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 II |
| Status | Terminated |
| Reason | It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. |
| Product | Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur. |
| Quantity | 32 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico. |
| Initiated | 2021-03-11 |
| Classified | 2021-04-09 |
| Terminated | 2024-10-29 |
| Recall number | Z-1380-2021 |
| 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 II recall — Arthrex, Inc. (Z-1380-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87584/
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