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Terminated

Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200. Distributed by Medtronic Xomed, Inc., Jacksonville, Florida 32216 U.S.A.

FDA Recall Z-0536-2010 · Posted 2009-12-15

Recalling FirmMedtronic Xomed, Inc.
Recall StatusTerminated
Product CodeLRK
Date Initiated2009-07-27
Date Terminated2010-03-15
Product Quantity13

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

9 consignees in the continental United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981677REPOSE BONE SCREW SYSTEMInfluence, Inc. · 1999-08-27

Official Source

View FDA Recall →

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

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