Zimmer, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1954-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 28, 2013

Date Posted: August 21, 2013

Recall Number: Z-1954-2013

Event ID: 65502

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.

Status: Terminated

Product Quantity: 3,163 both sizes

Code Information:

60720060 60729529 60782351 60875299 60902349 60948238 60943023 60985367 61019824 61034822 61063216 61145917 61183670 61207699 61218854 61356595 61400936 61515555 61566478 61615548 61756075 61780197 61832594 61864229 61923988 61978214 62041752 62136099 62180444 62226761 and 62289420

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.

Voluntary or Mandated:

Voluntary: Firm initiated