Zimmer, Inc.: CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384

Hazard

Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes 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

Details from the source

Reason for recall: Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes 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 Distribution: AL AZ CO FL LA MI OH OK TX Foreign: Canada Quantity: 1,168 untits Lot/code info: GTIN Number: 00889024283268 All lots

UPC codes

00889024283268

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.