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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument

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 Class 2 Recall
Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument
see related information
Date Posted September 11, 2008
Recall Status1 Terminated on November 12, 2009
Recall Number Z-1863-2008
Recall Event ID 48170
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
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.
Code Information Lots 60577285, 60582624, 60587308, 60603255 and 60610860.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
The instrument is prone to fracture during use.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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.
Quantity in Commerce 500
Distribution Nationwide, Australia, Canada, China, Germany, India, Japan, Korea, Mexico, Singapore, Spain, Sweden and Taiwan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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