Z-2567-2018 Class II Terminated
FDA device recall Z-2567-2018 was initiated by Howmedica Osteonics Corp. on December 21, 2017 and is designated Class II. 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. The recall status is terminated (terminated October 5, 2018). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- December 21, 2017
- Termination Date
- October 5, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
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.
Distribution Pattern
NY, FL, KS
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