Device product
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.
Z-2560-2014
Product summary
- Event
- Event 69050
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56 units
- Official record key
device-enforcement:Z-2560-2014
Official wording
Reason: Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
Code information: 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
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.