CLASS II Device recall · Reported 30 May 2018 · FDA Enforcement Report

Legion(R) CR Xlpe High Lexion Articular Insert, 5-6 Size recalled

Smith & Nephew is recalling Legion(R) CR Xlpe High Lexion Articular Insert, 5-6 Size. The recall was initiated on 30 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch Numbers: 11DM11664 & 15BM09445

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1906-2018
FDA event ID: 79875
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 30 Mar 2018
FDA classified: 22 May 2018
Reported: 30 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

30 Mar 2018	Recall initiated by company
22 May 2018	Classified by FDA	+53 days
30 May 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Batch Numbers: 11DM11664 & 15BM09445

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 79875

Reported	Class	Recall	Company	Reason	Where
30 May 2018	CLASS II	Legion(R) CR Xlpe High Lexion Articular Insert, 5-6 Size recalled	Smith & Nephew	Packaging Defects	TN
30 May 2018	CLASS II	Legion(R) CR Xlpe High Lexion Articular Insert, 5-6 Size recalled	Smith & Nephew	Packaging Defects	TN
30 May 2018	CLASS II	Legion(R) CR Xlpe High Lexion Articular Insert, 1-2 Size recalled	Smith & Nephew	Packaging Defects	TN

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