PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 30, 2018 Initiated: March 30, 2018 #Z-1906-2018

Product Description

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.

Reason for Recall

The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
N/A
Distribution
US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Smith & Nephew, Inc.. Units affected: N/A.
Why was this product recalled?
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 30, 2018. Severity: Moderate. Recall number: Z-1906-2018.