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Terminated

VariAx Compression Plating System

FDA Recall Z-1507-2016 · Posted 2016-04-18

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHWC
Date Initiated2013-10-10
Date Terminated2016-04-21
Product Quantity118 units

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.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130009VARIAX 2 COMPRESSION PLATING SYSTEMStryker Trauma AG · 2013-03-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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