Smith & Nephew, Inc.: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

Agency Publication Date: May 22, 2018

Affected Products

Product: 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.

Batch Number 16EM12620

Lot Numbers:

Number

Product: 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.

Batch Numbers: 09FM04561; 14AM05774 & 15GM11501

Lot Numbers:

Numbers

Product: 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.

Batch Numbers: 11DM11664 & 15BM09445

Lot Numbers:

Numbers

Product: 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.

Batch Numbers: 08BM09288; 12EM05884 & 12EM07720

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79875

Status: Resolved

Manufacturer: Smith & Nephew, Inc.

Manufactured In: United States

Units Affected: 3 products (16 units; 72 units; 47 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Batch Number 16EM12620

Lot Numbers:

Number

Batch Numbers: 09FM04561; 14AM05774 & 15GM11501

Lot Numbers:

Numbers

Batch Numbers: 11DM11664 & 15BM09445

Lot Numbers:

Numbers

Batch Numbers: 08BM09288; 12EM05884 & 12EM07720

Lot Numbers:

Numbers