—#108579

Product

REF 90-5970-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 10mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. 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 product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K003910, K892800, K933785, K951185
Affected lot / code info: Part 90-5970-031-10, all lots

Why it was recalled

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

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

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

Distribution

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.

Timeline

Recall initiated: 2012-02-24
Posted by FDA: 2012-05-14
Terminated: 2014-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108579. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.