Class 2 Device Recall OmniFit Eon

• Date Initiated by Firm: August 31, 2009
• Date Posted: January 11, 2010
• Recall Status: Terminated on July 17, 2013
• Recall Number: Z-0506-2010
• Recall Event ID: 53386
• 510(K)Number: K022555
• Product Classification: Surgical Literature - Product Code LZO
• Product: OmniFit Eon 127 degree and 132 degree Surgical Protocol; Stryker. Surgical protocols instruct surgeons on proper surgical technique.
• Code Information: Catalog Number/Lot Code: LSP48.
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah NJ 07430
• For Additional Information Contact: Ms. Colleen O'Meara; 201-831-5158
• Manufacturer Reason for Recall: Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
• FDA Determined Cause: Error in labeling
• Action: "Urgent Product Correction - Surgical Protocol" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747).
• Quantity in Commerce: 978
• Distribution: Worldwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LZO