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.
FDA Recall Z-2560-2014 · Posted 2014-08-29
Advertisement
Recalling FirmOrthoPediatrics Corp
Recall StatusTerminated
Product CodeMBI
Date Initiated2014-07-25
Date Terminated2015-05-19
Product Quantity56 units
Reason for Recall
Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
Firm Action
OrthoPediatrics sent a Notification letter dated July 25, 2014 to all affected customers. The letter Identified the affected product, problem and actions to be taken. The letter informed customers to take immediate possession of all affected product within their control and at any of their health care facilities and immediately return the recalled device(s) to OrthoPediatrics Corp. This notice and the attached Reply Form should be forwarded if the affected product was further distributed. .
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement