And yet, in January, the Zimmer Natural knee product known as the Zimmer Natural Knee II Durasul All-Poly Patella, Size 1, 10mm was recalled after reports that 16 patients suffered a shear of the patella peg.
The US Food and Drug Administration (FDA), the regulatory authority governing all medical devices and pharmaceutical drugs in this country, issued a Class 2 recall in tandem with manufacturer Zimmer at the beginning of the year. The recall of the Zimmer Natural Knee II followed the issuance of a so-called Urgent Device Recall letter dated December 20 of last year and sent to Zimmer's customers by the manufacturer.
The letter—a copy of which presumably went to the FDA—urged that distribution of the particular Zimmer Natural Knee system in question be immediately halted and all lots returned. According to a description of the communiqué contained in the FDA Class 2 recall announcement posted on January 25 of this year, recipients of the Zimmer letter were to furnish Zimmer with a list of all hospitals and surgeons having used the allegedly problematic device.
This statement assumes, however, that hospitals, surgeons or patients were not contacted directly from the outset.
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The only way for a patient to know, specifically, if they have received the recalled Natural Knee II Durasul All-Poly Patella, Size 1, 10mm is if they performed due diligence prior to surgery and noted, for their own records, the actual component received. Alternatively a call to or from a surgeon would yield to the patient this information, which may explain the source of either pain, a debilitating failure.
That said, this Zimmer Natural Knee II recall appears to have slipped under the radar, in a variety of different ways…