Home / Recalls / OrthoPediatrics Corp / Z-0579-2014

Z-0579-2014 Class II Terminated

Recalled by OrthoPediatrics Corp — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
January 1, 2014
Initiation Date
November 7, 2013
Termination Date
May 9, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40

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.

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.

Distribution Pattern

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

Code Information

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

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  • Z-2539-2020 Class II — OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model (June 5, 2020)
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  • Z-0597-2018 Class II — Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: P (August 3, 2017)
  • Z-2321-2017 Class II — Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-11 (April 24, 2017)