Class III — Pega Medical Inc.
| Recalling firm | Pega Medical Inc. |
|---|---|
| Registered facility | ORTHOPEDIATRICS CANADA ULC (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label. |
| Product | Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures. |
| Quantity | 3 units |
| Distribution | US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed. |
| Initiated | 2020-04-03 |
| Classified | 2020-05-15 |
| Terminated | 2020-11-20 |
| Recall number | Z-2038-2020 |
| 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 III recall — Pega Medical Inc. (Z-2038-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85531/
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