FDA-Device2023-04-05Class II
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
Zimmer, Inc.
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
Sold states
AL AZ CO FL LA MI OH OK TX Foreign: Canada
Affected count
1,168 untits
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1294-2023Don't want to check this manually?
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