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 4
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Code information
Batch Number 16EM12620
Distribution pattern
US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
device · product 2 of 4
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Code information
Batch Numbers: 09FM04561; 14AM05774 & 15GM11501
Distribution pattern
US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
device · product 3 of 4
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Code information
Batch Numbers: 11DM11664 & 15BM09445
Distribution pattern
US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
device · product 4 of 4
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
