Z-1953-2013 Class II Terminated
FDA device recall Z-1953-2013 was initiated by Zimmer, Inc. on Jun 28, 2013 and is designated Class II. 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… The recall status is terminated (terminated Mar 2, 2015). Affected quantity: 3,163.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 21, 2013
- Initiation Date
- Jun 28, 2013
- Termination Date
- Mar 2, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,163
Product Description
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.
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.
Distribution Pattern
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.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1953-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026