Zimmer NexGen CR-Flex Knee Replacement Potential Recall:

Contrary to a number of recently publicized reports, the Food and Drug Administration has NOT issued a recall for the entire line of the Zimmer NexGen CR-Flex Knee Replacement Device. Furthermore, Zimmer Holdings, the manufacturer of the device, has never, at any time to date (June 09, 2011), issued a voluntary recall of this aforementioned device.


Zimmer Recall

Some of the reasons for this widespread misconception can be linked to Dr. Richard Berger’s presentation at the 2010 American Association of Orthopedic Surgeons Meeting, where he revealed that in a study that he had conducted with fellow colleague, Dr. Craig J. Della Valle, early device failure occurred in approximately 8% of Zimmer NexGen CR-Flex Recipients studied, while another 36% of recipients studied showed signs and/or symptoms of “loosening” of the implanted device. Dr. Berger’s findings were also publicized in a New York Times article addressing the doctor’s struggles with Zimmer Holdings, and their refusal to grant any merit to his claims – thus adding to inaccurate speculation that the product had been recalled. While Dr. Berger’s findings did cause skepticism to arise regarding the integrity of the Zimmer NexGen CR-Flex Device, they did NOT amount to a proclamation that there had been a recall of the device.


Unfortunately for advertisers and websites who incorrectly stated that there had been a “Zimmer Knee Recall”, Zimmer took the offensive, and did not hesitate to file lawsuits against these companies and/or individuals for disseminating false and/or derogatory information about their product line.

It is important to note that the FDA, while NOT having issued a Zimmer NexGen CR-Flex Recall, has however issued recalls on two separate components that have been utilized in the Zimmer Knee Replacement Line: Specifically, according to the FDA Enforcement Reports referenced below, we know the following:


FDA Enforcement Report: November 10, 2010: The “Zimmer NexGen complete knee solution MIS total knee procedure stemmed Tibial component fixed bearing precoat sizes 1-10, and size 4+, sterile” were recalled because “the firm has received complaints of loosening of the implanted device requiring revision surgery.”*


FDA Enforcement Report: December 23, 2009: The “Zimmer Gender Solutions NexGen Complete Knee Solution, Legacy Knee, Posterior Stabilized, Gender Solutions Female, Femoral Component, option LPS-flex, size C, right, for cemented use only” was recalled because the inner package may interfere with the outer seal, resulting in a lack of assurance of sterility.*

* Whether or not either or both of these recalled components were readily utilized in the CR-Flex Knee Replacement Device may vary from patient to patient, depending on each patient’s individual circumstances and needs.

[Although no recall of the Zimmer NexGen CR-Flex Device has occurred to date, there is no guarantee that a recall of this specific device will not occur in the near to distant future. Monitoring information from the FDA, keeping up with the latest health news and tracking recent products defects announcements is a good way to stay informed about any developments with this product. The Sullo & Sullo website is also an extremely useful and informative tool in this capacity.]

If you or someone you know has experienced problems with a Zimmer NexGen CR-Flex Knee Replacement Device, the qualified and experienced Zimmer NexGen CR-Flex Knee Replacement Recall Attorneys at Sullo & Sullo, LLP would like to hear more about your case


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