CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report

various polyethylene implants BIO PLUG recalled by Zimmer Biomet

Zimmer Biomet is recalling various polyethylene implants BIO PLUG, distributed nationwide in the US. The recall was initiated on 17 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 163005 Lot 309030

Quantity recalled28,253 in total

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-1858-2017
FDA event ID: 76507
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 17 Feb 2017
FDA classified: 18 Apr 2017
Reported: 26 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

17 Feb 2017	Recall initiated by company
18 Apr 2017	Classified by FDA	+60 days
26 Apr 2017	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

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

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

various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.

Where it was distributed

Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK

Nationwide

Questions about this recall

Why was it recalled?

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Which lots are affected?

Item 163005 Lot 309030

Where was it sold?

Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK

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

5 other products · FDA event 76507

This product is part of a recall event; the main page for the event is various polyethylene implants Sports Med Repicci II Tibial recalled.

Reported	Class	Recall	Company	Reason	Where
26 Apr 2017	CLASS II	various polyethylene implants Sports Med Repicci II Tibial recalled	Zimmer Biomet	Other	Nationwide
26 Apr 2017	CLASS II	various polyethylene implants Knees Revision Tibial Tray recalled	Zimmer Biomet	Other	Nationwide
26 Apr 2017	CLASS II	various polyethylene implants Hips Active Articulation recalled	Zimmer Biomet	Other	Nationwide
26 Apr 2017	CLASS II	various polyethylene implants Extremities, Shoulders recalled	Zimmer Biomet	Other	Nationwide
26 Apr 2017	CLASS II	various polyethylene implants Custom parts recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide

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11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D. recalled	Zimmer Biomet	Sterility	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Sterility	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Sterility	Nationwide

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