Device product
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
Z-1294-2023
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 91842
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,168 untits
- Official record key
device-enforcement:Z-1294-2023
Official wording
Reason: 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
Code information: GTIN Number: 00889024283268 All lots
Distribution pattern: AL AZ CO FL LA MI OH OK TX Foreign: Canada
Derived failure modes
-
Unknown
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