CLASS II Device recall · Reported 11 Dec 2013 · FDA Enforcement Report

Genesis(r) Ii, Ps High Flexion Articular Insert, Size 5-6 Qty recalled

Smith & Nephew is recalling Genesis(r) Ii, Ps High Flexion Articular Insert, Size 5-6 Qty, distributed in Nevada. The recall was initiated on 27 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch No. 12GT20904

Quantity recalled32 pieces

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-0447-2014
FDA event ID: 66333
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 27 Aug 2013
FDA classified: 4 Dec 2013
Reported: 11 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

27 Aug 2013	Recall initiated by company
4 Dec 2013	Classified by FDA	+99 days
11 Dec 2013	Published in enforcement report	+7 days

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

Reason for recall

The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

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

GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

Where it was distributed

Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.

Nevada

Questions about this recall

Why was it recalled?

The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Which lots are affected?

Batch No. 12GT20904

Where was it sold?

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

5 other products · FDA event 66333

This product is part of a recall event; the main page for the event is Genesis(r) Ii, Posterior Stabilized Articular Insert, Size 1-2 Qty recalled.

Reported	Class	Recall	Company	Reason	Where
11 Dec 2013	CLASS II	Genesis(r) Ii, Posterior Stabilized Articular Insert, Size 1-2 Qty recalled	Smith & Nephew	Packaging Defects	NV
11 Dec 2013	CLASS II	Genesis(r) Ii, Ps High Flexion Articular Insert, Size 5-6 Qty recalled	Smith & Nephew	Packaging Defects	NV
11 Dec 2013	CLASS II	Genesis(r) Ii, Ps High Flexion Articular Insert, Size 3-4 Qty recalled	Smith & Nephew	Packaging Defects	NV
11 Dec 2013	CLASS II	Genesis(r) Ii, Ps High Flexion Articular Insert, Size 3-4 Qty recalled	Smith & Nephew	Packaging Defects	NV
11 Dec 2013	CLASS II	Genesis(r) Ii, Mobile Bearing Articular Insert Right, Size 5 Qty recalled	Smith & Nephew	Packaging Defects	NV

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