CLASS II Device recall · Reported 21 Aug 2013 · FDA Enforcement Report

REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System recalled

Zimmer is recalling REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System, distributed nationwide in the US. The recall was initiated on 28 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes60729528 60720059 60782350 60803204 60811712 60889765 60909408 60943022 60948237 60989841 60985366 61019823 61051119 61034821 61140638 61178017 61207698 61237374 61304005 61338570 61356591 6381187 61400935 61431685 61463330 61487660 61521267 61544005 61585968 61627734 61704564 61735029 61772406 61794587 61817713 61858701 61850103 61877862 61950512 61998686 61972672 62010251 62018071 62041751 62078963 62096387 62121179 62136094 62141873 62158509 62180443 62203390 62215390 62249372 62271566 62298060

Quantity recalled3,163

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-1953-2013
FDA event ID: 65502
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 28 Jun 2013
FDA classified: 12 Aug 2013
Reported: 21 Aug 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

28 Jun 2013	Recall initiated by company
12 Aug 2013	Classified by FDA	+45 days
21 Aug 2013	Published in enforcement report	+9 days

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

Reason for recall

There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor.

Where it was distributed

Worldwide Distribution - USA (nationwide) and internationally to Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Korea, Lebanon, Malta, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Utd.Arab.Emir.

Nationwide

Questions about this recall

Is REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System recalled?

Yes. Zimmer recalled REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System on 28 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-1953-2013.

Why was it recalled?

Which lots are affected?

60729528 60720059 60782350 60803204 60811712 60889765 60909408 60943022 60948237 60989841 60985366 61019823 61051119 61034821 61140638 61178017 61207698 61237374 61304005 61338570 61356591 6381187 61400935 61431685 61463330 61487660 61521267 61544005 61585968 61627734 61704564 61735029 61772406 61794587 61817713 61858701 61850103 61877862 61950512 61998686 61972672 62010251 62018071 62041751 62078963 62096387 62121179 62136094 62141873 62158509 62180443 62203390 62215390 62249372 62271566 62298060

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 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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