Device product
VariAx Compression Plating System
Z-1507-2016
Product summary
- Event
- Event 73505
- Status
- Terminated
- Classification
- Class II
- Quantity
- 118 units
- Official record key
device-enforcement:Z-1507-2016
Official wording
Reason: Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
Code information: catalog numbers 629503S, 629504S, 629505S, 629506S, 629507S, 629508S, 629509S, 629510S, 629527S, 629537S, 629543S, 629544S, 629545S, 629546S, 629547S, 629548S, 629559S, 629560S, 629561S, 629562S, 629564S, 629566S, 629568S, 629570S
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.