FDAFDA · Food and drugs·Recall number Z-2560-2014
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.
Published September 10, 2014 · Recall initiated: July 25, 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
Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- OrthoPediatrics Corp
- Distributor
- US Nationwide Distribution.
- Lot
- Part #: Lot Code: 01-1008-0040 132762 01-1008-0041 F132764, F132763 01-1008-0042 F132763, F132764 01-1008-0043 F132765, F132766 01-1008-0044 F132766, F132765 01-1008-0045 F132768 01-1008-0046 F132769 01-1008-0047 F132770
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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