FDA Medical Device Recalls (openFDA)
Medtronic Xomed, Inc.: 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.
- Recall number
- Z-0535-2010
- 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.
- Status
- Terminated
- Initiated
- 2009-07-27
- Posted
- 2009-12-15
- Terminated
- 2010-03-15
- Reason
- 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
- 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
- 7
- Distribution
- 9 consignees in the continental United States.
- Lot, serial or model codes
- Lot # 62450300
- 510(k) numbers
- ["K981677"]
- PMA numbers
- not on file
- Product code
- LRK
- Firm FEI
- 1045254
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28