Recall Z-1507-2016— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-1507-2016
Creator: U.S. Food and Drug Administration
Published: 2013-10-10

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2013-10-10, terminated 2016-04-21. It names one FDA 510(k) clearance: K130009. Product: VariAx Compression Plating System. Reason: Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-10-10
Terminated: 2016-04-21
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K130009 — VARIAX 2 COMPRESSION PLATING SYSTEMStryker Trauma AG·cleared 2013-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VariAx Compression Plating System

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.