Howmedica Osteonics Corp.: Medical Device Recall in 2018 - (Recall #: Z-2567-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 21, 2017

Date Posted: August 8, 2018

Recall Number: Z-2567-2018

Event ID: 79485

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.

Status: Terminated

Product Quantity: 5

Code Information:

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

Distribution Pattern:

NY, FL, KS

Voluntary or Mandated:

Voluntary: Firm initiated