Z-2567-2018Class II

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

Name: Z-2567-2018 Custom Made Implant System with Minimum Invasive Grower (MIG) component
Creator: Howmedica Osteonics Corp.
Published: 2017-12-21
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2017-12-21 / Terminated / root cause: labeling and UDI

FDA source

Howmedica Osteonics Corp. began a recall of Custom Made Implant System with Minimum Invasive Grower (MIG) component on 2017-12-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2567-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-21
Posted: 2018-07-28
Terminated: 2018-10-05
Recalling firm: Howmedica Osteonics Corp
Product: Custom Made Implant System with Minimum Invasive Grower (MIG) component
Product code: JDO Device, Fixation, Proximal Femoral, Implant
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On December 21, 2017 a FIELD SAFETY NOTICE was issued to customers notifying of the corrective action. An attachment was supplied with the letter titled "Minimally Invasive Grower - Instructions For Adjustment that is effective on and after October 14, 2014. Questions or concerns can be directed to your local sales representative.
Quantity in commerce: 5
Distribution: NY, FL, KS
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2567-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2567-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28

Product code JDO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)