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.
Reported: September 10, 2014 Initiated: July 25, 2014 #Z-2560-2014
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.
Details
- Recalling Firm
- OrthoPediatrics Corp
- Units Affected
- 56 units
- Distribution
- US Nationwide Distribution.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by OrthoPediatrics Corp. Units affected: 56 units.
Why was this product recalled? ▼
Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2014. Severity: Moderate. Recall number: Z-2560-2014.
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