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

FDA device recall Z-1954-2013 · posted 2013-08-12 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

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, Ko

Date initiated

2013-06-28

Date posted

2013-08-12

Date terminated

2015-03-02

Location

Warsaw, IN