Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile. This device is a surgical instrument used during knee arthroplasty procedures to snap or lock the polyethylene bearing surface into the retaining rail on a metal tibial plate.
FDA Recall Z-1863-2008 · Posted 2008-09-11
Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2008-05-16
Date Terminated2009-11-12
Product Quantity500
Reason for Recall
The instrument is prone to fracture during use.
Firm Action
Direct and hospital consignees were notified via email or letter on 5/16/08 to cease use and return the instruments.
Contact Kevin W. Escapule at 800-846-4637 if you have questions.
Root Cause
Process control
Distribution Pattern
Nationwide, Australia, Canada, China, Germany, India, Japan, Korea, Mexico, Singapore, Spain, Sweden and Taiwan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.