Class II — Toby Orthopaedics, Inc.
| Recalling firm | Toby Orthopaedics |
|---|---|
| Registered facility | TOBY ORTHOPAEDICS (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential suture clip breaking during a humerus fixation surgery. |
| Product | PANTERA Proximal Humerus Fracture Plate System |
| Quantity | 1700 devices |
| Distribution | Arkansas, Florida, Puerto Rico, Spain, Panama, Australia, UK |
| Initiated | 2013-06-05 |
| Classified | 2019-12-04 |
| Terminated | 2020-09-16 |
| Recall number | Z-0599-2020 |
| 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 — Toby Orthopaedics, Inc. (Z-0599-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83963/
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