CLASS II Device recall · Reported 8 Jul 2015 · FDA Enforcement Report

Natural Knee II Revision Femoral Stem recalled by Zimmer

Zimmer is recalling Natural Knee II Revision Femoral Stem, distributed nationwide in the US. The recall was initiated on 2 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesitem 6215-12-185 Lots: 7884165 7884736 7884737 7884738 7890330 11011448 11012660 60394169 60415420 60515793 60564530 60601129 60614014 60797044 60803056 60841848 60922655 60922656 60927853 60989112 61017152 61104192 61135872 61200531 61284571 61366919 61464308 61505310 61533025 61566733 61742151 61780361 61784264 61834192 61834778 61840307 61930376 61947884 61947885 62097910 62146925 62195165 62249431 62281270 62305675 62317987 62358643 62448678 62536901 62536902 62536903 62546527 62560372 62587577 62610989 62624715 62624716 62624717 62624718 62709664 62709665 62709667 62709670

Quantity recalled352

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-1948-2015
FDA event ID: 71531
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 2 Oct 2014
FDA classified: 1 Jul 2015
Reported: 8 Jul 2015
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

2 Oct 2014	Recall initiated by company
1 Jul 2015	Classified by FDA	+272 days
8 Jul 2015	Published in enforcement report	+7 days

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

Reason for recall

Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection.

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

Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.

Where it was distributed

US Nationwide Distribution, including DC and the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MT, NC, ND, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, and WY.

Nationwide Alabama Arizona California Colorado District of Columbia Florida Georgia Illinois Indiana Kansas Louisiana Maryland Michigan Minnesota Missouri Montana North Carolina North Dakota New Jersey New York

Questions about this recall

Why was it recalled?

Which lots are affected?

item 6215-12-185 Lots: 7884165 7884736 7884737 7884738 7890330 11011448 11012660 60394169 60415420 60515793 60564530 60601129 60614014 60797044 60803056 60841848 60922655 60922656 60927853 60989112 61017152 61104192 61135872 61200531 61284571 61366919 61464308 61505310 61533025 61566733 61742151 61780361 61784264 61834192 61834778 61840307 61930376 61947884 61947885 62097910 62146925 62195165 62249431 62281270 62305675 62317987 62358643 62448678 62536901 62536902 62536903 62546527 62560372 62587577 62610989 62624715 62624716 62624717 62624718 62709664 62709665 62709667 62709670

Where was it sold?

US Nationwide Distribution, including DC and the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MT, NC, ND, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, and WY.

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.

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