VariAx Compression Plating System
- Recall Initiated
- October 10, 2013
- Posted
- April 18, 2016
- Terminated
- April 21, 2016
- Recall Number
- Z-1507-2016
- Quantity
- 118 units
- Firm Location
- Mahwah, NJ
Reason for Recall
Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
Distribution
Nationwide Distribution
Lot / Code Info
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
Root Cause
Device Design
Action Taken
Stryker Orthopaedics sent notification letters/product accountability forms on October 10, 2013, via email. Customers are provided the product issue, hazards and risk mitigation along with actions needed. Customers should receive the affected products and complete the BRF and return to Stryker. Questions can be directed to Stryker. For further questions, please call (201) 831-5000.