The FDA isn't happy with orthopedic device company Extremity Medical. Regulators smacked down the company for a number of alleged quality, problem-reporting and approval violations regarding the production of various screws and other implants.
The agency's Feb. 24 warning letter dings the Parsippany, NJ-based enterprise for allegedly making changes to some of its products without telling regulators or gaining approval first. The agency also takes the company to task for not reporting a product malfunction. For example, the letter points to a broken lag screw at the joint of a Hallux device, whose "malfunction may result in non-union of the patient's joint." What's more, the FDA says the company hasn't reported problems promptly and lacks a way to efficiently report complaints.
Regulators also claim that the company violated quality system regulations by not adequately testing or inspecting devices, including its compression screw. FDA inspectors pulled 8 of 26 screws for scrutiny and found one that was undersized. Such manufacturing is supposed to produce zero rejects, and so the screw lot should have been kept back for additional inspection, regulators say.
The FDA says it conducted an inspection of the company from Sept. 28 through Oct. 24. Extremity must respond within 15 business days of receiving the warning letter. FierceMedicalDevices attempted to contact Extremity Medical, and an employee who handled the call declined to comment. The company launched in 2008 and produces implants and screws used in orthopedic surgery on distal extremities, including the hand, wrist, foot and ankle, according to the company's website.