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Recall Observatory FDA recall evidence

Device 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.

Z-1905-2018

March 30, 2018

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 79875
Status
Terminated
Classification
Class II
Quantity
72 units
Official record key
device-enforcement:Z-1905-2018

Official wording

Reason: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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