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MDRs required though device no longer made.(Food and Drug Administration investigated Medical Device Reporting at Hospital for Special Surgery)(Brief Article)
Inspection Monitor
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April 1, 1999
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Hospital for Special Surgery, New York, NY, New York District.
A January 1998 audit of the Hospital for Special Surgery (HSS) showed that FDA expected continuing Medical Device Reporting (MDR) com-pliance although the hospital had stopped making hip, elbow and knee implants.
According to the recently released EIR, which was accompanied by a recall report, HSS began making standard orthopedic devices in 1988. It stopped producing standard devices in 1992 and custom devices in 1996. These custom items were distributed only to HSS and, in some cases, ...
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