openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
Custom Made Implant System with Minimum Invasive Grower (MIG) component
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.
These labels are deterministic app interpretations, not FDA categories.
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.
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
