FDA Device recall Z-2567-2018
Custom Made Implant System with Minimum Invasive Grower (MIG) component
- FDA Device
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of Custom Made Implant System with Minimum Invasive Grower (MIG) component by Howmedica Osteonics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2567-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-21 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Howmedica Osteonics |
| Distribution | FL, KS, NY |
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.
Identifiers
| code_info | Manufactured between March 2007 and October 2014 Prosthesis Identification Number (PIN) Date of Dispatch 16082 11A…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2567-2018%22
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