Class II — Pega Medical Inc.
| Recalling firm | Pega Medical Inc. |
|---|---|
| Registered facility | ORTHOPEDIATRICS CANADA ULC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The Male Components in this lot are made of material with lower strength than manufacturing specifications. |
| Product | Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod. |
| Quantity | Total of 5 units (2 units in the US and 3 units in Germany) |
| Distribution | Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany. |
| Initiated | 2014-02-07 |
| Classified | 2014-04-10 |
| Terminated | 2014-04-23 |
| Recall number | Z-1448-2014 |
| 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 — Pega Medical Inc. (Z-1448-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67675/
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