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| Clearview Wrist Fixation System--courtesy of Rigid FX |
The FDA is warning Rigid FX Orthopedics for quality system and medical device reporting violations at its Austin, TX, facility. Rigid makes a product called the Clearview Wrist Fixation System to treat distal radius fractures. And regulators, in a warning letter dated Nov. 2, 2012 and posted this week, claim the product production, in part, lacks a system to ensure the device is made according to design requirements. Additionally, the FDA cited Rigid for not having any procedures through which to handle complaints, among other critiques. Rigid was required to report steps to correct violations and how it would prevent them in the future. Warning Letter