Class II — Ortho Development Corporation
| Recalling firm | Ortho Development Corporation |
|---|---|
| Registered facility | ORTHO DEVELOPMENT CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A femoral component containing pegs was found in a box for the pegless version. |
| Product | PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures. |
| Quantity | 5 |
| Distribution | US Nationwide Distribution in the states of NV, and AZ. |
| Initiated | 2014-04-01 |
| Classified | 2014-05-12 |
| Terminated | 2014-07-14 |
| Recall number | Z-1610-2014 |
| 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 — Ortho Development Corporation (Z-1610-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68029/
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