NEW YORK, March 12, 2013 (GLOBE NEWSWIRE) -- Metal-on-metal hip implant maker Stryker announced* this week that it received a warning from the U.S. Food and Drug Administration related to concerns about quality at its Portage, Mich., factory. The Rottenstein Law Group, which represents clients in Stryker recall lawsuits, is monitoring the news with concern.
Stryker was also cited by the FDA for failing to inform the regulator of a product recall and for marketing the Neptune Waste Management System without a 510(k) clearance, according to the Dow Jones Newswire. The concerns about the facility stemmed from a November 2012 inspection.
"The 2012 recall of the Stryker Rejuvenate and the ABG II was voluntary, and it occurred amid the FDA's increased scrutiny of the various metal-on-metal hip replacement systems on the market," said Rochelle Rottenstein, principal of the Rottenstein Law Group. "In this case, the FDA has become more stringent in doing its duty. We welcome this."
The Rottenstein Law Group manages an informational website designed to help those who believe they have suffered injuries evaluate if they have a case.
Stryker Recall
In July 2012 Stryker, based in Kalamazoo, Mich., announced a recall of both its Rejuvenate and ABG II hip replacements because of a potential for corrosion and fretting that could result in adverse local tissue reactions and possible pain and swelling around the hip, according to Stryker's website.**
Stryker told Reuters*** that it has submitted corrective plans to the FDA.
*nasdaq.com/article/stryker-gets-fda-warnings-letter-for-failing-to-notify-agency-of-recall-20130312-00480#.UT85roletEI
**stryker.com/en-us/products/Orthopaedics/modularneckstems/index.htm
***reuters.com/article/2013/03/12/us-stryker-fdawarning-idUSBRE92B0J020130312
About THE ROTTENSTEIN LAW GROUP
The Rottenstein Law Group is a New York-based firm that represents clients nationwide in mass tort actions. The firm was founded by Rochelle Rottenstein, who has more than two decades of experience as a lawyer, to represent clients hurt by defective medical devices. (Attorney advertising. Prior results do not guarantee a similar outcome.)