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U.S. Department of Health and Human Services

Class 2 Device Recall ULTRAPOWER DIAMOND WHEEL Burs

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 Class 2 Recall
ULTRAPOWER DIAMOND WHEEL Burs
see related information
Date Posted September 08, 2009
Recall Status1 Terminated on May 11, 2010
Recall Number Z-2041-2009
Recall Event ID 52804
Product Classification Burr, Orthopedic - Product Code HTT
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.
Code Information All lots manufactured from July 01, 2004 and April 31, 2008.
Recalling Firm/
Manufacturer
Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo, Florida 33773-4908
Manufacturer Reason
for Recall
ConMed Linvatec is recalling Ultrapower Bur, Diamond Wheel for possibility of a packaging breach in the sterile barrier.
FDA Determined
Cause 2
DESIGN: Packaging 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 in Commerce 2502
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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