—#70927

Product

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 product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lots 60577285, 60582624, 60587308, 60603255 and 60610860.

Why it was recalled

The instrument is prone to fracture during use.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Australia, Canada, China, Germany, India, Japan, Korea, Mexico, Singapore, Spain, Sweden and Taiwan.

Timeline

Recall initiated: 2008-05-16
Posted by FDA: 2008-09-11
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70927. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.