CLASS II Device recall · Reported 3 Sep 2014 · FDA Enforcement Report

Endo & Unipolar Femoral Heads recalled by Zimmer

Zimmer is recalling Endo & Unipolar Femoral Heads: Endo Femoral Head Dia Endo Femoral Head Dia Endo Femoral. The recall was initiated on 22 Jul 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem Numbers 00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500, 00781805700, 00781806000, 00781806300, 00902604101, 00902604201, 00902604301, 00902604401, 00902604501, 00902604601, 00902604701, 00902604801, 00902604901, 00902605001, 00902605101, 00902605201, 00902605301, 00902605401, 00902605501, 00902605701, 00902606001, 00902606301, 451000041, 451000042, 451000043, 451000044, 451000045, 451000046, 451000047, 451000048, 451000049, 451000050, 451000051, 451000052, 451000053, 451000054, 451000055, 451000056, 451000057, 451000058, 451000059, 451000060 EXPIRATION DATE PRIOR TO 2024-01

Quantity recalled972,125 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-2547-2014
FDA event ID: 68818
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 22 Jul 2014
FDA classified: 26 Aug 2014
Reported: 3 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

22 Jul 2014	Recall initiated by company
26 Aug 2014	Classified by FDA	+35 days
3 Sep 2014	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

Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM DIA ENDO FEMORAL HEAD 50MM DIA ENDO FEMORAL HEAD 51MM DIA ENDO FEMORAL HEAD 52MM DIA ENDO FEMORAL HEAD 53MM DIA ENDO FEMORAL HEAD 54MM DIA ENDO FEMORAL HEAD 55MM DIA ENDO FEMORAL HEAD 57MM DIA ENDO FEMORAL HEAD 60MM DIA ENDO FEMORAL HEAD 63MM DIA ENDO FEM HEAD 41MM ENDO FEM HEAD 42MM ENDO FEM HEAD 43MM ENDO PROS HEAD 44MM ENDO FEM HEAD 45MM ENDO FEM HEAD 46MM ENDO FEM HEAD 47MM ENDO FEM HEAD 48MM ENDO FEM HEAD 49MM ENDO FEM HEAD 50MM ENDO FEM HEAD 51MM ENDO FEM HEAD 52MM ENDO FEM HEAD 53MM ENDO FEM HEAD 54MM ENDO FEM HEAD 55MM ENDO FEM HEAD 57MM ENDO FEM HEAD 60MM ENDO FEM HEAD 63MM UNIPOLAR COMPONENT, 41MM UNIPOLAR COMPONENT, 42MM UNIPOLAR COMPONENT, 43MM UNIPOLAR COMPONENT, 44MM UNIPOLAR COMPONENT, 45MM UNIPOLAR COMPONENT, 46MM UNIPOLAR COMPONENT, 47MM UNIPOLAR COMPONENT, 48MM UNIPOLAR COMPONENT, 49MM UNIPOLAR COMPONENT, 50MM UNIPOLAR COMPONENT, 51MM UNIPOLAR COMPONENT, 52MM UNIPOLAR COMPONENT, 53MM UNIPOLAR COMPONENT, 54MM UNIPOLAR COMPONENT, 55MM UNIPOLAR COMPONENT, 56MM UNIPOLAR COMPONENT, 57MM UNIPOLAR COMPONENT, 58MM UNIPOLAR COMPONENT, 59MM UNIPOLAR COMPONENT, 60MM

Where it was distributed

Worldwide Distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

Item Numbers 00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500, 00781805700, 00781806000, 00781806300, 00902604101, 00902604201, 00902604301, 00902604401, 00902604501, 00902604601, 00902604701, 00902604801, 00902604901, 00902605001, 00902605101, 00902605201, 00902605301, 00902605401, 00902605501, 00902605701, 00902606001, 00902606301, 451000041, 451000042, 451000043, 451000044, 451000045, 451000046, 451000047, 451000048, 451000049, 451000050, 451000051, 451000052, 451000053, 451000054, 451000055, 451000056, 451000057, 451000058, 451000059, 451000060 EXPIRATION DATE PRIOR TO 2024-01

Where was it sold?

Worldwide Distribution.

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 21 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

6 other products · FDA event 68818

This product is part of a recall event; the main page for the event is Moore & Thompson Hip Stems: Fnstrd Hip 38HDX127ST Fnstrd recalled.

Reported	Class	Recall	Company	Reason	Where
3 Sep 2014	CLASS II	Moore & Thompson Hip Stems: Fnstrd Hip 38HDX127ST Fnstrd recalled	Zimmer	Sterility	IN
3 Sep 2014	CLASS II	Knee Instrument Fixation Screws recalled by Zimmer	Zimmer	Sterility	IN
3 Sep 2014	CLASS II	Knee Stem Extensions & Impactor Sleeve recalled by Zimmer	Zimmer	Sterility	IN
3 Sep 2014	CLASS II	Trauma Tubes and Plates: Tube & Scp Plt 90DX150LG Tube recalled	Zimmer	Sterility	IN
3 Sep 2014	CLASS II	Trauma Large Screws: Cann Bone Screw 7.0MMX100MMLG Cann recalled	Zimmer	Sterility	IN
3 Sep 2014	CLASS II	Endo & Unipolar Femoral Heads: Endo Femoral Head Dia recalled by Zimmer	Zimmer	Sterility	IN

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All 539

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1 Jul 2026Device	CLASS II	Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment recalled	Zimmer	Foreign Material	IN
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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	Nitrosamine Impurity	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)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide