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Terminated

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.

FDA Recall Z-1904-2018 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2018-03-30
Date Terminated2019-08-21
Product Quantity16 units

Reason for Recall

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

Firm Action

The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.

Root Cause

Packaging process control

Distribution Pattern

US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071071CROSSLINKED POLYETHYLENE ARTICULAR INSERTSSmith & Nephew, Inc. · 2007-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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