OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.
FDA Recall Z-0579-2014 · Posted 2013-12-26
Recalling FirmOrthoPediatrics Corp
Recall StatusTerminated
Product CodeMBI
Date Initiated2013-11-07
Date Terminated2014-05-09
Product Quantity40
Reason for Recall
Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
Firm Action
November 7, 2013 all consignees were notified of the Urgent Device recall via telephone calls and E-mail messages describing the product and reason for the recall,. The notice included directions to identify and quarantine the recalled devices returning product to OrthoPediatrics with completed return form to OrthoPediatrics via mail, email or courier service, or by
photographing with a smart phone and emailing to [email protected] or by answering the
recall specific questionsin an email to [email protected]
Root Cause
Labeling design
Distribution Pattern
Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
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.