Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer, Warsaw, Indiana; REF 5951-90..
FDA Recall Z-2301-2008 · Posted 2008-09-20
Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHWA
Date Initiated2008-06-30
Date Terminated2009-11-12
Product Quantity1439
Reason for Recall
The instrument may fracture during use, resulting in metal fragments being left in the patient post-surgery, which could cause implant failure.
Firm Action
Consignees were notified via letter dated 6/30/08. The letter described the issue, provided instructions for the return of the product and asked customers to complete a reply back form. For assistance, contact Zimmer at 1-574-372-4487.
Root Cause
Device Design
Distribution Pattern
Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.