Home / Recalls / OrthoPediatrics Corp / Z-0276-2014

Z-0276-2014 Class II Terminated

Recalled by OrthoPediatrics Corp — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
November 20, 2013
Initiation Date
September 26, 2013
Termination Date
December 26, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7 units shipped

Product Description

3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.

Reason for Recall

The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.

Distribution Pattern

Worldwide Distribution - US including Michigan and the countries of Ireland and Australia

Code Information

Part Number:. 00-0903-2634 and lot number 009U2

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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)