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U.S. Department of Health and Human Services

Class 2 Device Recall Repose G2 Bone Screw System

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  Class 2 Device Recall Repose G2 Bone Screw System see related information
Date Initiated by Firm July 27, 2009
Date Posted December 15, 2009
Recall Status1 Terminated 3 on March 15, 2010
Recall Number Z-0535-2010
Recall Event ID 52837
510(K)Number K981677  
Product Classification Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea - Product Code LRK
Product Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300.

Distributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A.

The Repose G@ Bone Screw System is composed of the Repose Bone Screw (a miniature, self-tapping screw attached to polypropylene suture), the Repose Bone Screw Inserter (a battery operated, disposable device that deploys the screw), the Repose Suture Passer, and the Repose Tongue Retractor.
Code Information Lot # 62450300
Recalling Firm/
Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information Contact
Manufacturer Reason
for Recall
Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.
FDA Determined
Cause 2
Labeling mix-ups
Action Firm notified customers by phone on 7/27/2009. Firm asked customers to check inventories for the affected products listed on the enclosed Checklist. 1. Fill-in the "quantity on-hand "column on the checklist. 2. If you have any this product lot, contact Medtronic ENT Customer Service at 800-874-5797 (select Option 1 for Customer Service) and ask for the REPOSE Field Action Contact Person for help to arrange for returns and replacements or credit. 3. Fax your Checklist to Medtronic ENT at the number provided. 4. Return products clearly marked.
Quantity in Commerce 7
Distribution 9 consignees in the continental United States.
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 = LRK and Original Applicant = INFLUENCE, INC.