00-5972-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 12mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.
FDA Recall Z-1571-2012 · Posted 2012-05-14
Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2012-02-24
Date Terminated2014-04-18
Product Quantity83,322 all sizes
Reason for Recall
Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Firm Action
Zimmer sent an Urgent Correction Notice dated March 5, 2012, to all affected customers via telephone, E-mail and letter notifying users of the appropriate compatibility of micro sizes of NexGen CR and CR-Flex Articular Surfaces and informing them of known cases of incompatible devices being implanted, including associated risks. Customers and surgeons were asked to acknowledge receipt by calling 1-888-912-7349. Questions and concerns or help in notiying accounts about this correction were to be addressed to 1-888-548-8514.
For questions regarding this recall call 574-372-4807.
Root Cause
Labeling design
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Poland, Taiwan, Denmark, Korea, Singapore, China, Canada, Australia, Japan, France, Italy, UK, Germany, Spain, Belgium, Portugal, Switzerland, Sweden, India, Thailand, Peru, The Netherlands, Malaysia, and Austria.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K003910NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTSZimmer, Inc. · 2001-03-19K951185NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACEZimmer, Inc. · 1996-03-15K933785NEXT GENERATION KNEE SYSTEMZimmer, Inc. · 1995-01-30K892800MG II POROUS TOTAL KNEE SYSTEMZimmer, Inc. · 1989-08-03
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.