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 | Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures mainly occurred in patients with tibial pseudoarthrosis (CPT) or Osteogenesis imperfecta (OI). Higher failure rates have been detected in tibias with distal fractures that are close to the distal locking holes. |
| Product | GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medu… |
| Quantity | 7 units distributed in the US; |
| Distribution | US Nationwide Distribution in the states of: California, Florida, New York, and Puerto Rico (US). |
| Initiated | 2015-02-20 |
| Classified | 2015-04-01 |
| Terminated | 2015-04-30 |
| Recall number | Z-1362-2015 |
| 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-1362-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70630/
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