—#71987

Product

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 product code: HWA — Impactor
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All units.

Why it was recalled

The instrument may fracture during use, resulting in metal fragments being left in the patient post-surgery, which could cause implant failure.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan.

Timeline

Recall initiated: 2008-06-30
Posted by FDA: 2008-09-20
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71987. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.