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Zimmer Inc., an orthopedics device manufacturer based in Warsaw, Indiana has recalled a key component used in its knee resurfacing and replacement product, the Zimmer Persona Personalized Knee System. That component is the porous coated, uncemented Zimmer Persona Trabecular Metal Tibial Plate. 1
Trabecular Metal Tibial Plate Recall
In February 2015, Zimmer ceased shipping the Zimmer Persona Personalized Knee System’s porous coated, uncemented Trabecular Metal Tibial Plate and voluntarily withdrew it from the market. In March 2015, the U.S. Food and Drug Administration categorized that recall as a Class II. 2
The FDA approved the Zimmer Persona Personalized Knee System for marketing within the U.S. in 2012. Zimmer obtained that approval using the FDA’s expedited 510(k) application process.
The 510(k) process allows a device maker to bring a new product to market without first subjecting it to as rigorous clinical testing as is required for “pre-market approval” (PMA) devices. To do so requires that the new product is substantially similar to another product already approved by the FDA. 3
Zimmer initiated its recall after multiple event reports were submitted to the FDA and appeared in the FDA’s MAUDE database. Many of those reported events involved device loosening or lines on X-ray film.