Medical Devices Assembly

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SYLMAR, CA—The FDA is inspecting St. Jude Medical Inc.’s assembly plant here after the company recalled defibrillators with defective cable assemblies.

WASHINGTON—The U.S. Food and Drug Administration has warned Zimmer Holdings Inc. about its practices for manufacturing and testing hip implants at an assembly plant in Puerto Rico.

MENTOR, OH— Medical device manufacturer Steris Corp. is building a new, $11 million assembly plant here.

The growth of medical device reprocessing is forcing OEMs to rethink how they design and assemble their products.

LITHIA SPRINGS, GA—Medline Industries is spending $35 million to expand its assembly plant here by 50 percent, less than a year after it opened. The company plans to hire additional workers to support the new assembly lines.

ROCKY HILL, CT—Henkel Corp. is hosting a seminar Sept. 26 in Minneapolis that will cover adhesives for medical device assembly.

LAKE FOREST, IL—Hospira Inc. has received a warning letter from the FDA stemming from an April inspection of the company’s medical device assembly plant in La Aurora de Heredia, Costa Rica.

CANTON, IL—Cook Medical has opened a new, $19 million factory here to make PTFE tubing for medical devices. The plant will employ 60.

WASHINGTON—The FDA is planning to develop a new unique device identification system to track high-risk medical devices.

Low-volume, low-pressure technology enables clean application of materials such as grease, reagents, marking inks and adhesive activators.