FDAFDA · Food and drugs·Recall number Z-2057-2012
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.
Published August 1, 2012 · Recall initiated: June 14, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- OrthoPediatrics Corp
- Distributor
- Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
- Lot
- Lot number: 7736703 and part number: 00-1050-4308
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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