Recall Z-2567-2018 ยท JDO Device, Fixation, Proximal Femoral, Implant
Howmedica Osteonics Corp.
Custom Made Implant System with Minimum Invasive Grower (MIG) component
| Date | Dec 21, 2017 |
| Status | Terminated |
| Reason | 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 | Labeling design |
| Action | 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. |
| Quantity | 5 |
| Distribution | NY, FL, KS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.