FDA Recall
Terminated
Custom Made Implant System with Minimum Invasive Grower (MIG) component
Recall: Z-2567-2018
·
Initiated December 21, 2017
Recall
- Recall Number
- Z-2567-2018
- Event Number
- 79485
- Firm
- Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- JDO
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- December 21, 2017
- Terminated
- October 5, 2018
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2006
Description
Custom Made Implant System with Minimum Invasive Grower (MIG) component
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.
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.
Distribution
NY, FL, KS
Quantity
5