OrthoPediatrics PediLoc Locking Plate System — Class II medical device recall Z-2057-2012
Terminated recall by OrthoPediatrics Corp, reported 2012-08-01, distributed in FL, GA, IN, MI, MO, OH, SC. The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
| Recall number | Z-2057-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2012-06-14 |
| Classified | 2012-07-20 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2013-04-30 |
| Distributed | FL, GA, IN, MI, MO, OH, SC |
| Countries outside the US | AU |
| Quantity | 15 devices |
| Reason classes | labeling |
| Lot numbers | 7736703 |
| Model numbers | 00-1050-4308 |
Product
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
Reason for recall
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2057-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.