—#162447

Product

Custom Made Implant System with Minimum Invasive Grower (MIG) component

FDA product code: JDO — Device, Fixation, Proximal Femoral, Implant
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Manufactured between March 2007 and October 2014 Prosthesis Identification Number (PIN) Date of Dispatch 16082 11Apr 2011 18313 19 Dec 2013 18666 20 Jun 2014 18713 15 Sep 2014 18800 29 Aug 2014

Why it was recalled

From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.

Root cause (FDA determination)

Labeling design

Action the firm took

On December 21, 2017 a FIELD SAFETY NOTICE was issued to customers notifying of the corrective action. An attachment was supplied with the letter titled "Minimally Invasive Grower - Instructions For Adjustment that is effective on and after October 14, 2014. Questions or concerns can be directed to your local sales representative.

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: NY, FL, KS

Timeline

Recall initiated: 2017-12-21
Terminated: 2018-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162447. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.