CDRH: Continued Vigilance Needed for Chinese Titanium

U.S. Food and Drug Administration (FDA) officials are encouraging device manufacturers to continue monitoring titanium alloy imported from China for a potential defect.

There have been no injuries or device failures linked to the defect since it first surfaced late last summer, but medical device manufacturers nonetheless should remain vigilant in their supplier controls, officials with the FDA’s Center for Devices and Radiological Health (CDRH) claim. CDRH administrators are advising companies to determine the impact of the material specification problem and take appropriate corrective actions such as recalls.

Authorities traced the defective titanium to a manufacturing plant in China. Though it met industry standards established by ASTM International (a standards organization based in West Conshohocken, Pa.), the titanium contained a defect known as alloy segregation, meaning the metals were not melded homogenously. Such an improper melding process could possibly cause the metals to remain unmixed.

The defective raw material made its way from China to distributors, and eventually to at least 130 manufacturers that used the titanium in products (predominantly orthopedic goods), said Timothy A. Ulatowski, director of the Office of Compliance within the CDRH. Over the last several decades, titanium has become a standard material for medical devices such as hip and knee joints, bone screws and plates, dental implants, surgical devices, pacemaker cases and centrifuges due to its high strength and biocompatibility, low modulus and its compatibility with both MRI (magnetic resonance imaging) and CT (computed tomography) procedures.

One of the suppliers of the tainted titanium was G&S Titanium Inc., a Wooster, Ohio-based bar, coil and wire mill. G&S CEO Roger Geiser said his company received the raw material from Dalian Sunny Titanium Industry Ltd., a 7-year-old Chinese firm co-owned by Hong Ji Material Limited Company and the Research Institute of Chinese Academy of Science. G&S Titanium, however, stopped purchasing titanium from Dalian after the problem was first reported by an unnamed device manufacturer.

That manufacturer, according to published reports, was unable to process titanium through a machine used to make its product (the specific device was never identified). The FDA learned of the problem after the manufacturer approached its supplier, G&S, which in turn, notified Dalian of the defect. The FDA visited G&S’s facility, but details about that inspection were not released.

Officials from the FDA and the Orthopedic Surgical Manufacturer’s Association have been working with affected device firms to address the issue, but it has not been an easy task. For starters, only a destructive test could possibly identify the defect, and such a test would weaken the titanium, industry experts noted. In addition, the defect could be so localized that only a small piece of one device actually could be defective.

G&S tested the titanium it received from Dalian and found it to be within industry standards for strength and chemistry specifications.