Zimmer Switzerland Manufacturing GmbH, ZFA2022-00302, CoCr Femoral Heads

Zimmer GmbH is conducting a medical device Field Safety Corrective Action (correction) to update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS. The update is to remove the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009). When used in combination with the Epsilon Durasul Constrained Acetabular Liner, the CoCr Femoral Head XS has a range of motion of 76 degrees. The reduced range of motion could potentially result in the health risks identified in the table below. There have been no complaints for this issue.