FDA Device recall Z-2057-2012
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right
- FDA Device
- Class II
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class II recall of OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right by Orthopediatrics, citing the device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2057-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-14 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Orthopediatrics |
| Distribution | FL, GA, IN, MI, MO, OH, SC |
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
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Identifiers
| code_info | Lot number: 7736703 and part number: 00-1050-4308 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2057-2012%22
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