Recall Z-2560-2014— OrthoPediatrics Corp
Class II · Terminated
Class II FDA medical device recall by OrthoPediatrics Corp, initiated 2014-07-25, terminated 2015-05-19. It names one FDA 510(k) clearance: K130217. 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.. Reason: Weld fractures on the Sleeve Installation Tool for ACL reconstruction system..
- Recalling firm
- OrthoPediatrics Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-25
- Terminated
- 2015-05-19
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.