FDAClass IIApril 27, 2016

VariAx Compression Plating System recall

VariAx Compression Plating System

Why was VariAx Compression Plating System recalled?

Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
VariAx Compression Plating System
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
118 units
Distribution
Nationwide Distribution
Recall date
April 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls