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Zimmer, Inc. recalls REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsteri
Recalled August 21, 2013 · FDA recall Z-1954-2013 · Zimmer
Hazard
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. · FDA Class II
Units
3,163 both sizes
Sold at
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.
Description
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.
Product
REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 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.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →