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U.S. Department of Health and Human Services

Class 2 Device Recall OnmiFit HFx Surgical Protocol

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  Class 2 Device Recall OnmiFit HFx Surgical Protocol see related information
Date Initiated by Firm August 31, 2009
Date Posted January 11, 2010
Recall Status1 Terminated 3 on July 17, 2013
Recall Number Z-0507-2010
Recall Event ID 53386
510(K)Number K022555  
Product Classification Surgical Literature - Product Code LZO
Product OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive, Mahwah, NJ 07430.

Surgical protocols instruct surgeons on proper surgical technique.
Code Information Catalog Number/Lot Code: LSP46.
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Ms. Colleen O'Meara
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 2
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 2,876
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 and Original Applicant = HOWMEDICA OSTEONICS CORP.