Z-1954-2013Class II

REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm...

Name: Z-1954-2013 REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm...
Creator: Zimmer, Inc.
Published: 2013-06-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-06-28 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1 Instrumentation used in... on 2013-06-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1954-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-28
Posted: 2013-08-12
Terminated: 2015-03-02
Recalling firm: Zimmer GmbH
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer Inc sent Urgent Medical Device Recall notifications on June 28, 2013, to all affected customers. The initial letter identified the issue, possible adverse consequences and informed customers that a replacement would be available in the coming months. In addition, the letter included references to both the TM Reverse Surgical Technique and to the video available on Zimmer TV and Zimmer.com. Both resources explain in detail the proper technique for utilization of the Glenosphere Helmet. Proper utilization of the Glenosphere Helmet dramatically reduces the likelihood of fracture. Distributors will receive a copy of the surgeon letter for their reference along with the list of affected surgeons. The affected surgeons will be identified using invoice data and in cases where the surgeon is unknown, the distributor will be instructed to assist with the surgeon list. In addition, information regarding the return process for the damaged devices will be included. Questions and concerns are directed to Zimmer's customer call center (1-877-946-2761). Phase 2: As replacement devices with the new design became available for distribution, a 2nd letter was sent to the distributors. Estimated replacement device availability will begin in July 2013. The distributors will be instructed to order replacement devices as a means of completing the affected instrument cases in circulation within their territories. Instructions for the return of devices were included. For questions regarding this recall call 800-613-6131.
Quantity in commerce: 3,163 both sizes
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1954-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1953-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-12
Z-1954-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-12

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)