Stryker Recalls Hip Implants After Warning
Stryker is voluntarily recalling certain implants manufactured at its Cork, Ireland, facility after discovering a deviation from its internal specifications.
The company announced the recall of Trident PSL and Hemispherical Acetabular Cups Jan. 22, saying it reviewed the plant in response to a March 2007 warning letter on certain hip implants manufactured there.
According to Stryker, the investigation found the products met U.S. and international sterility standards, but testing showed manufacturing residuals in some cases exceeded the company’s internal acceptance criteria. Therefore, it initiated the voluntary recall.
The March warning letter cited Stryker for not appropriately documenting its risk analysis, root cause investigations and verification measures for a packaging procedure correction. 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.
Stryker said it expects some short-term supply disruption because of the current recall, but the manufacturing process for these cups in Cork has been validated, product shipments have resumed and the company has increased production at that facility as well as in New Jersey.