FDA Medical Device Recalls (openFDA)
Linvatec Corp. dba ConMed Linvatec: ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is USA. ST ULTRAPOWER Diamond Wheel/MDS M-51, (MUSTARD) 25.4 mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702129200, STERILE. Made in USA. ST ULTRAPOWER Diamond Wheel/MDS AM-51, (LIME) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702139200, STERILE. Made in USA. ST ULTRAPOWER BUR Diamond Wheel/MDS TU-51 (TEAL) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702149200, STERILE. Made is USA. Single use devices. CONMED LINVATEC 11311 Concept Blvd Largo, FL 33773-4908 Surgical instrument motors and accessories are AC-powered, or air-powered devices intended for the use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, a chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.
- Recall number
- Z-2041-2009
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Product
- ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is USA. ST ULTRAPOWER Diamond Wheel/MDS M-51, (MUSTARD) 25.4 mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702129200, STERILE. Made in USA. ST ULTRAPOWER Diamond Wheel/MDS AM-51, (LIME) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702139200, STERILE. Made in USA. ST ULTRAPOWER BUR Diamond Wheel/MDS TU-51 (TEAL) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702149200, STERILE. Made is USA. Single use devices. CONMED LINVATEC 11311 Concept Blvd Largo, FL 33773-4908 Surgical instrument motors and accessories are AC-powered, or air-powered devices intended for the use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, a chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.
- Status
- Terminated
- Initiated
- 2009-07-31
- Posted
- 2009-09-08
- Terminated
- 2010-05-11
- Reason
- ConMed Linvatec is recalling Ultrapower Bur, Diamond Wheel for possibility of a packaging breach in the sterile barrier.
- Root cause
- Package design/selection
- Action
- Firm notified international and domestic consignees by an Urgent Medical Device Recall letter on July 31, 2009. Customers were asked to check their inventory; complete, sign, and return the enclosed Reply Form; and return the devices for credit. Questions should be directed to Customer Service at 1-800-237-0169.
- Quantity
- 2502
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- All lots manufactured from July 01, 2004 and April 31, 2008.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTT
- Firm FEI
- 1017294
- Firm city
- Largo
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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