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U.S. Department of Health and Human Services

Class 2 Device Recall Richard Wolf Medical Istruments

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  Class 2 Device Recall Richard Wolf Medical Istruments see related information
Date Initiated by Firm November 25, 2015
Date Posted February 09, 2016
Recall Status1 Terminated 3 on August 21, 2017
Recall Number Z-0790-2016
Recall Event ID 73091
510(K)Number K984304  
Product Classification Arthroscope - Product Code HRX
Product Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
Code Information Affected lot 0207201502.
Recalling Firm/
Manufacturer		 Richard Wolf Medical Instruments Corp.
353 Corporate Woods Pkwy
Vernon Hills IL 60061-3110
For Additional Information Contact Lisa Williams
847-913-1113 Ext. 225
Manufacturer Reason
for Recall		 Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
FDA Determined
Cause 2		 Process control
Action The firm sent an URGENT Medical Device Recall letter dated 11/25/2015 to consignees informing them of the recall and the actions needed to be taken. These included to not use the affected burr and to destroy the device. The user is also instructed to fill out the Recall Action Response Form to acknowledge receipt of the notification. The form should be scanned to Dsantostefano@richardwolfusa.com or mailed to: Dawn Santostefano, Recall Coordinator Richard Wolf Medical instruments 353 Corporate Woods Parkway Vernon Hill, IL 60061
Quantity in Commerce four units
Distribution Distributed in Washington.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = RICHARD WOLF MEDICAL INSTRUMENTS CORP.
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