FDAFDA · Food and drugs·Recall number Z-0934-2014
3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
Published February 12, 2014 · Recall initiated: January 8, 2014
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
OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- OrthoPediatrics Corp
- Distributor
- Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany.
- Lot
- Lot 009SV
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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