CLASS II Device recall · Reported 13 Jan 2016 · FDA Enforcement Report

Genesis(r) Ii/legion(tm) Patellar Component recalled by Smith & Nephew

Smith & Nephew is recalling Genesis(r) Ii/legion(tm) Patellar Component, Resurfacing Round Standard, For Cemented Use, distributed in Florida, Indiana, Missouri, Texas. The recall was initiated on 9 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch # 15GM07831

Quantity recalled20 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-0573-2016
FDA event ID: 72866
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 9 Nov 2015
FDA classified: 4 Jan 2016
Reported: 13 Jan 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

9 Nov 2015	Recall initiated by company
4 Jan 2016	Classified by FDA	+56 days
13 Jan 2016	Published in enforcement report	+9 days

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

Reason for recall

One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.

Product as listed by the FDA

Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.

Where it was distributed

US Distribution to states of:FL, MO, IN and TX.

Florida Indiana Missouri Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Batch # 15GM07831

Where was it sold?

US Distribution to states of:FL, MO, IN and TX.

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.

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