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REF 00-5972-031-14, Nextgen Complete Knee System, Prolong… recallZ-1587-2012 · Zimmer Inc. · initiated Feb 24, 2012

Terminated All recalls posted in May 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Labeling design

What the company is doing

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.

Recall details

Recall number
Z-1587-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 24, 2012
Posted by the FDA
May 14, 2012
Recalling firm
Zimmer Inc.
Quantity
83,322 all sizes
Product code
JWH
FDA submissions
K003910, K892800, K933785, K951185
Distribution
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.

Product description

REF 00-5972-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 14mm 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.

Code information (models, lots, serial numbers)

Part 00597203114, all lots

Other devices under the same FDA submission

99 devices cleared under K003910, K892800, K933785, K951185 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 61468).

Sources and updates

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