Reported Apr 27, 2016 · Terminated
VariAx Compression Plating System
Stryker Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- VariAx Compression Plating System
- Lot codes and dates
catalog numbers 629503S629504S629505S629506S629507S629508S629509S629510S629527S629537S629543S629544S629545S629546S629547S629548S629559S629560S629561S629562S629564S629566S629568S629570S
- Amount recalled
- 118 units
Where it was sold
- Nationwide
Why it was recalled
Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
This product could cause temporary or reversible health problems — stop using it.
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