Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

NexGen Complete Knee Solution Rotating Hinge Knee tibial broach impactor, Catalog # 00-5881-080-00, Zimmer Inc., Warsaw, IN.

FDA Recall Z-0610-2011 · Posted 2010-12-13

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-04-16
Date Terminated2012-09-12
Product Quantity10,666 both products

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.

Firm Action

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

Distribution Pattern

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, Germany, Guatemala, Hong Kong, India, Italy, Japan, Korea, Mexico, Netherlands, Nicaragua, Panama, Peru, Portugal, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑