Device product
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
Z-2445-2015
Product summary
- Event
- Event 71461
- Status
- Terminated
- Classification
- Class II
- Quantity
- 112
- Official record key
device-enforcement:Z-2445-2015
Official wording
Reason: The device may have improper screw hole placement due to inaccurate location of the index line.
Code information: H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097
Distribution pattern: US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
Derived failure modes
-
Unknown
The device may have improper screw hole placement due to inaccurate location of the index line.