NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.

FDA device recall Z-0609-2011 · posted 2010-12-13 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

The impactor may disassemble or detach during use. The detached piece may not be observed intraoperatively and may be left in the surgical site. Complications may include pain, infection, and prolongation in surgery. These complications may also require revision surgery.

Action taken

Zimmer issued "Urgent Medical Device Safety Alert" letters dated April 16, 2010 to Risk Managers, user facilities, Health Care Professionals and Zimmer Sales force. The users were informed to inspect the device for loosening. The alert also informed users to inspect the device after each use to verify that the device was intact. Customers were instructed to complete and return a User Facility Documentation Form. Zimmer will repair and replace all affected devices. Customers can contact ZImmer, Inc. at 800 613-6131 concerning this recall.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

10,666 all products.

Distribution

Worldwide Distribution: Throughout US including Puerto Rico, and the countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Denmark, Ecuador, El Salvador, France,

Date initiated

2010-04-16

Date posted

2010-12-13

Date terminated

2012-09-12

Location

Warsaw, IN

Related 510(k) clearances