FDA recall Z-2567-2018

Product

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.

Distribution

NY, FL, KS

Key facts

Status

Terminated

Initiation date

2017-12-21

Report date

2018-08-08

Termination date

2018-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2567-2018