—#144321

Product

VariAx Compression Plating System

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K130009
Affected 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

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2013-10-10
Posted by FDA: 2016-04-18
Terminated: 2016-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144321. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.