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 | There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out. |
| Product | SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery |
| Quantity | 31 devices |
| Distribution | Nationwide distribution to CA, FL, GA, HI, LA, MA, MO, NC, NY, OK. International distribution to AUSTRALIA, CANADA, DENMARK, GERMANY, ISRAEL, MEXICO, ROMANIA, RUSSIA, UNITED ARAB EMIRATES, UNITED KINGDOM |
| Initiated | 2019-10-02 |
| Classified | 2019-11-01 |
| Terminated | 2020-10-26 |
| Recall number | Z-0270-2020 |
| 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-0270-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84017/
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