FDAnews Device Daily Bulletin

Stryker: Company Is in Compliance Following Warning Letter

July 20, 2007

Following its response to an FDA warning letter regarding its manufacturing facility in Cork, Ireland, Stryker considers its operations in full compliance with agency regulations, saying it has already employed the necessary corrective actions, the company told D&DL.

The agency issued the letter March 15 to Stryker’s Ireland operations following inspections Oct. 31 to Nov. 3, 2006. The facility primarily manufactures Duracon and Scorpio knee replacement components, as well as hip replacement systems such as Trident Acetabular, according to the letter, which was posted recently to the FDA website.

Stryker was cited for not appropriately documenting the required elements of risk analysis and root cause investigations and verification or effectivity measures regarding a correction for a packaging procedure, the letter said. In addition, a root cause investigation was not initiated and corrective and preventive actions were not taken for a nonconformance of inner- and outer-blister test samples for lots of CoCr hip stems.