Recall Z-2567-2018— Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2017-12-21, terminated 2018-10-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-21
- Terminated
- 2018-10-05
- Firm location
- Mahwah, NJ, United States
Product description
Custom Made Implant System with Minimum Invasive Grower (MIG) component
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.