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 | SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. |
| Product | SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic. |
| Quantity | 4 units distributed in the US |
| Distribution | Distributed in the states of FL and TN. |
| Initiated | 2015-10-20 |
| Classified | 2015-11-20 |
| Terminated | 2016-08-16 |
| Recall number | Z-0324-2016 |
| 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 — Pega Medical Inc. (Z-0324-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72529/
Alerts for Pega Medical Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.