OrthoPediatrics Corp: Medical Device Recall in 2014 - (Recall #: Z-0579-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 7, 2013

Date Posted: January 1, 2014

Recall Number: Z-0579-2014

Event ID: 67003

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.

Status: Terminated

Product Quantity: 40

Code Information:

Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770

Distribution Pattern:

Nationwide Distribution including the states of CA, KY, OH, RI, and TN.

Voluntary or Mandated:

Voluntary: Firm initiated