Z-0535-2010

Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed by Medtronic Xomed, Inc...

Name: Z-0535-2010 Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed by Medtronic Xomed, Inc...
Creator: Medtronic Xomed, Inc.
Published: 2009-07-27
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2009-07-27 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Xomed, Inc. began a recall of 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... on 2009-07-27. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0535-2010
Status: Terminated
Initiated: 2009-07-27
Posted: 2009-12-15
Terminated: 2010-03-15
Recalling firm: Medtronic Xomed, Inc.
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.
Product code: LRK Device, Anti-Snoring
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Lot # 62450300

Product code LRK

K981677Class IIRepose Bone Screw SystemInfluence, Inc. / cleared 1999-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)