CLASS II Device recall · Reported 17 Dec 2014 · FDA Enforcement Report

Legion(tm) Cocr Constrained Femoral Component, Size 6, Left recalled

Smith & Nephew is recalling Legion(tm) Cocr Constrained Femoral Component, Size 6, Left, distributed nationwide in the US. The recall was initiated on 4 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 14EM23391

Quantity recalled23 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-0591-2015
FDA event ID: 69759
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 4 Nov 2014
FDA classified: 11 Dec 2014
Reported: 17 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

4 Nov 2014	Recall initiated by company
11 Dec 2014	Classified by FDA	+37 days
17 Dec 2014	Published in enforcement report	+6 days

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

Reason for recall

The stem taper on this device is undersized; the gauge point is not deep enough.

Product as listed by the FDA

LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.

Where it was distributed

Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.

Nationwide Iowa Michigan Minnesota Missouri Ohio Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

The stem taper on this device is undersized; the gauge point is not deep enough.

Which lots are affected?

Lot Number 14EM23391

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

2 other products · FDA event 69759

This product is part of a recall event; the main page for the event is Legion(tm) Cocr Constrained Femoral Component, Size 5, Right recalled.

Reported	Class	Recall	Company	Reason	Where
17 Dec 2014	CLASS II	Legion(tm) Cocr Constrained Femoral Component, Size 5, Right recalled	Smith & Nephew	Other	Nationwide
17 Dec 2014	CLASS II	Legion(tm) Cocr Constrained Femoral Component, Size 4, Left recalled	Smith & Nephew	Other	Nationwide

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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