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 | Handle could jam with the Driver due to the detachment of an internal Connector Ring. |
| Product | SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System |
| Quantity | 19 |
| Distribution | CA, DE, FL, IL, NC, NE, NY and TN |
| Initiated | 2019-05-29 |
| Classified | 2019-08-14 |
| Terminated | 2021-01-15 |
| Recall number | Z-2278-2019 |
| 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-2278-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83372/
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