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 | Potential for polystyrene particulate presence. |
| Product | BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. |
| Quantity | 138 total products |
| Distribution | Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI. |
| Initiated | 2016-04-22 |
| Classified | 2016-06-14 |
| Terminated | 2017-10-13 |
| Recall number | Z-1959-2016 |
| 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 II recall — Arthrex, Inc. (Z-1959-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74084/
Alerts for ARTHREX, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.