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 hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage. |
| Product | Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number. |
| Quantity | 9 units (5 units in the US and 4 units international) |
| Distribution | Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom. |
| Initiated | 2015-04-10 |
| Classified | 2015-04-29 |
| Terminated | 2015-06-29 |
| Recall number | Z-1546-2015 |
| 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-1546-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71061/
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