Biomet has received a warning letter from the FDA regarding its Signature personalized patient care system, a pre-operative surgical planning offering for knee replacement procedures. The agency maintains the company hasn't received appropriate clearance or approval to market the system in the U.S.
The company responded to the agency Aug. 3, explaining why it believes that the system, which is manufactured by Materialise NV, has been appropriately marketed under a 510(k) premarket clearance. Biomet says in a statement that it is committed to working with the FDA to resolve the issue in the best interests of patients and their doctors without disruption to patient treatment.
Separately, a recently approved tax abatement for Biomet will help the devicemaker create 278 jobs at its Warsaw, Indiana facility and allow for a $26 million capital improvements project. The project will include funding for building improvements, machinery and equipment, investments in R&D and tooling and IT.
- check out the warning letter
- read the Biomet statement on the warning letter
- get more from Mass Device
- see the Times-Union report on the tax abatement