Stryker Corporation (SYK) recently resolved two warning letters issued by the U.S. Food and Drug Administration (FDA). The FDA has given a clean certificate to Stryker after it found that the actions undertaken by the company to address issues raised in these letters were sufficient.

In 2007, Stryker received a warning letter from the FDA regarding compliance issues with regard to certain quality system requirements at its reconstructive implant manufacturing facility in Cork, Ireland. In 2009, Stryker received another warning letter from the FDA related to compliance issues for one of its craniomaxillofacial (CMF) implant products. These products were sold through the company’s CMF distribution facility in Portage, Michigan.

Stryker took corrective actions at both its Cork and CMF facilities. The FDA has informed Stryker that no further formal corrective actions are required.

We think that the settlement of these issues is a great relief for Stryker as it saves the company from incurring additional legal expenses and an erosion of its bottom line. Stryker reported first quarter fiscal 2010 earnings per share of 80 cents, surpassing the Zacks Consensus Estimate of 78 cents and the year-ago earnings of 71 cents.

Stryker is one of the world’s largest medical devices companies operating in the global orthopedic market. In the orthopedic space, Stryker competes with major players, such as Zimmer Holdings Inc. (ZMH), CONMED Corporation (CNMD), Smith & Nephew (SNN), Johnson & Johnson/DePuy (JNJ) and Wright Medical Group Inc. (WMGI). Currently, we have a ‘Neutral’ recommendation on Stryker.

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