Class II — CarboFix Orthopedics, Ltd.
| Recalling firm | CarboFix Orthopedics Ltd. |
|---|---|
| Registered facility | CarboFix Orthopedics, Ltd. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility. |
| Product | Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. |
| Quantity | 638 |
| Distribution | AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA |
| Initiated | 2016-05-10 |
| Classified | 2016-06-14 |
| Terminated | 2017-01-27 |
| Recall number | Z-1991-2016 |
| 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 — CarboFix Orthopedics, Ltd. (Z-1991-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74229/
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