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
Unity Total Knee System. Used for knee prosthesis in total knee replacement
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
Code information
Model Number: 112.040.06; Lot Number: 504337
Distribution pattern
Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
