FDAFDA · Food and drugs·Recall number Z-2796-2015
3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
Published September 30, 2015 · Recall initiated: July 28, 2015
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 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- OrthoPediatrics Corp
- Distributor
- Domestic: TN, IA Foreign: England VA/DOD: None
- Lot
- Part number 00-0903-2510, Lot number 150192-J
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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