Device 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.
Z-2057-2012
Product summary
- Event
- Event 62351
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 devices
- Official record key
device-enforcement:Z-2057-2012
Official wording
Reason: The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Code information: Lot number: 7736703 and part number: 00-1050-4308
Distribution pattern: Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
Derived failure modes
-
Labeling or packaging
incorrectly labeled