CLASS II Device recall · Reported 9 Jul 2014 · FDA Enforcement Report

NexGen Complete Knee Solution, MIS Total Knee Procedure recalled

Zimmer is recalling NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, distributed nationwide in the US. The recall was initiated on 19 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSize 6, includes the following Lot Numbers: 370319 37213647 37218135 37218727 37219556 37220950 61414605 61414606 61442322 61451224 61451225 61451226 61479488 61479489 61479490 61518197 61518198 61518199 61538053 61543978 61592093 61592094 61627261 61643938 61672569 61682157 61685470 61721675 61721676 61774189 61774190 61774191 61774195 61863158 61863159 61863160 61863161 61863162 61979034 61979035 62016163 62022560 62037896 62041306 62041308 62069549 62077856 62141261 62143609 62168186 62177113 62227421 62227422 62251569 62251570 62261977 62261978 62326316 62330687 62341281 62369796 62369797 62377652 62473295 62473296 62602804 62602805 62602806 62602807 62602808

Quantity recalled41,180 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-1937-2014
FDA event ID: 68457
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 19 May 2014
FDA classified: 27 Jun 2014
Reported: 9 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Hip & Knee Implants

Timeline

19 May 2014	Recall initiated by company
27 Jun 2014	Classified by FDA	+39 days
9 Jul 2014	Published in enforcement report	+12 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 initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.

Nationwide

Questions about this recall

Is NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component recalled?

Yes. Zimmer recalled NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component on 19 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1937-2014.

Why was it recalled?

Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Which lots are affected?

Size 6, includes the following Lot Numbers: 370319 37213647 37218135 37218727 37219556 37220950 61414605 61414606 61442322 61451224 61451225 61451226 61479488 61479489 61479490 61518197 61518198 61518199 61538053 61543978 61592093 61592094 61627261 61643938 61672569 61682157 61685470 61721675 61721676 61774189 61774190 61774191 61774195 61863158 61863159 61863160 61863161 61863162 61979034 61979035 62016163 62022560 62037896 62041306 62041308 62069549 62077856 62141261 62143609 62168186 62177113 62227421 62227422 62251569 62251570 62261977 62261978 62326316 62330687 62341281 62369796 62369797 62377652 62473295 62473296 62602804 62602805 62602806 62602807 62602808

Where was it sold?

Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.

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.

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