Z-1904-2018Class II

smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use...

Name: Z-1904-2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use...
Creator: Smith & Nephew, Inc.
Published: 2018-03-30
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2018-03-30 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. began a recall of 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... on 2018-03-30. FDA classified it as Class II and gives the reason as "The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1904-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-30
Posted: 2018-05-22
Terminated: 2019-08-21
Recalling firm: Smith & Nephew, Inc.
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.
Quantity in commerce: 16 units
Distribution: US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
Product codes and lots: Batch Number 16EM12620

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1904-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1904-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-22
Z-1905-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-22
Z-1906-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-22
Z-1907-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-22

Product code JWH

K071071Class IICrosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. / cleared 2007-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)