Stryker Corp, a provider of orthopaedic implants as well as medical and surgical equipment, has been informed by the FDA that the actions undertaken by the company to address the issues raised in a 2007 warning Letter are sufficient.
Stryker has received the warning letter from FDA regarding compliance with certain quality system requirements at its reconstructive implant manufacturing facility in Mahwah, New Jersey in 2007.
Following FDA re-inspection in 2009 and additional corrective actions, Stryker has been informed that issues raised have been adequately addressed and no further formal corrective actions are required.
Stephen MacMillan, chairman, president and chief executive officer of Stryker, said: “The resolution of the Mahwah, New Jersey Warning Letter is another important step in demonstrating our firm commitment to significantly transforming our quality systems throughout our organization. The investments we have made, and will continue to make, are resulting in solid progress toward our goals.”
Stryker is a provider of orthopaedic implants as well as medical and surgical equipment to help people lead more active and more satisfying lives.