Inspections, Compliance, Enforcement, and Criminal Investigations
Stryker Craniomaxillofacial Division 5/5/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
300 River Place
Detroit, MI 48207
May 5, 2009
RETURN RECEIPT REQUESTED
Stephen P. MacMillan, President & CEO
2825 Airview Blvd.
Kalamazoo, MI 49002
Dear Mr. MacMillan:
During an inspection of your firm located at 750 Trade Centre Way, Suite 200, Portage, MI on December 8-10, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm distributes the Stryker Custom Cranial Implant. Under section 201(h)of the Federal Food, Drug, and Cosmetic (the Act), 21 U.S.C. 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law. Specifically, this device is adulterated within the meaning of section 501 (f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). This device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the modified device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3l22.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The Stryker Custom Cranial Implant device was cleared on April 15, 2005, premarket notification (510(k)) submission number K043250, as a non-sterile device. Our investigation determined that there have been significant changes or modifications in design, components, method of manufacture, or intended use, that require submission of a new premarket notification in accordance with 21 CFR 807.81(a)(3). Specifically, in or around October 2007, you began marketing and labeling the device as sterile. We have determined that this change could significantly affect the safety of the device.
Accordingly, a new 510(k) must be submitted for this change or modification in the device that could significantly affect the safety or effectiveness of the device. 21 CFR 807.81(a)(3)(i).
The device is also misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 806 - Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to, the following:
• Failure to include required information in the report of correction or removal submitted to FDA, as required by 21 CFR 806.10(c). For example, the report of correction or removal that your firm submitted to the Detroit District Office on October 23, 2008, did not contain the manufacturer's name address, telephone number, and contact person if different from that of the person submitting the report. 21 CFR 806.10(c)(6). Your report of correction or removal stated that Stryker Leibinger GmbH & Co, Freiburg, Germany was the manufacturer; however, our investigation determined that Contract Medical Manufacturing (CMM), Oxford, CT is the manufacturer.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Your written response should be sent to Steven B. Barber, Director, Compliance Branch, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Mr. Steven B. Barber at (313) 393-8110.
Joann M. Givens
Detroit District Office