CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report

Genesis(r) Ii, Non-porous Tibial Base, Size 6, Right, Qty recalled

Smith & Nephew is recalling Genesis(r) Ii, Non-porous Tibial Base, Size 6, Right, Qty, distributed nationwide in the US. The recall was initiated on 7 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch No. 13GM09505

Quantity recalled4 units

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-0131-2014
FDA event ID: 66545
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 7 Oct 2013
FDA classified: 1 Nov 2013
Reported: 13 Nov 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

7 Oct 2013	Recall initiated by company
1 Nov 2013	Classified by FDA	+25 days
13 Nov 2013	Published in enforcement report	+12 days

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

Reason for recall

Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

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, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic

Where it was distributed

USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.

Nationwide Arizona Iowa Maryland North Carolina Ohio Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

Which lots are affected?

Batch No. 13GM09505

Where was it sold?

USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.

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

1 other product · FDA event 66545

Reported	Class	Recall	Company	Reason	Where
13 Nov 2013	CLASS II	Genesis(r) Ii, Non-porous Tibial Base, Size 5, Left, Qty recalled	Smith & Nephew	Packaging Defects	Nationwide

More recalls from Smith & Nephew

All 258

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Trigen Proximal Straight Humeral Nail recalled by Smith & Nephew	Smith & Nephew	Other	DE
24 Dec 2025Device	CLASS II	Biosure HA Screw Threaded metallic bone fixation fastener recalled	Smith & Nephew	Labeling Errors	Nationwide
28 May 2025Device	CLASS II	Meta-tan Lag/compression Screw Kit recalled by Smith & Nephew	Smith & Nephew	Other	Nationwide
11 Dec 2024Device	CLASS II	Bioraptor Suture Anchors recalled by Smith & Nephew	Smith & Nephew	Sterility	Nationwide
13 Nov 2024Device	CLASS II	Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner recalled by Smith & Nephew	Smith & Nephew	Other	TN

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide