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U.S. Department of Health and Human Services

Class 2 Device Recall Arthrex Reciprocating Saw Attachment

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  Class 2 Device Recall Arthrex Reciprocating Saw Attachment see related information
Date Initiated by Firm May 24, 2011
Date Posted July 25, 2011
Recall Status1 Terminated 3 on October 09, 2015
Recall Number Z-2879-2011
Recall Event ID 59146
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Product Arthrex Reciprocating Saw Attachment
Type: V-600SR
Distributed by: Arthrex Inc., Naples, Florida United States

The system Is a modular electric system, consisting of a handpiece drive, various accessories, and a charging station for machining bones. It can be used in the following areas of application: orthopaedic and A&E Interventions, such as osteotomies, large and small bone operations, and joint replacement operations. The charging station is intended exclusively for charging V 600 Li-Ion and V 300 LiIon rechargeable batteries
Code Information Serial Numbers: 1106 through1310
Recalling Firm/
Manufacturer		 W & H DentalWerk Buermoos GMBH
53 Ignaz-Glazer-Strasse
Burmoos Austria
Manufacturer Reason
for Recall		 Reciprocating saw attachment V 600 Sr (REF: 17306210), screws can become loose or come off (the attachment) and fall into the surgical wound and may not be noticed due to its small size.
FDA Determined
Cause 2		 Equipment maintenance
Action Madrimed GmbH (Distributor partner) of W&H Dentalmechanik GmbH sent a letter dated May 24, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were ask to advise their users to check the adapters thoroughly before and after each application, until the conversion of all attachments have been completed and to send all products that need to be converted to the nearest service centers. W&H decided to convert all products that might be affected in their service centres and equip them with an additional security device. If you have any questions, call +43627462360 or email: regulatory@wh.com.
Quantity in Commerce 194 units
Distribution Worldwide distribution: USA (nationwide) and countries of: Austia, Australia, Canada, Czech Republic, Denmark, France, Germany, Italy, Kuwait, Malaysia, Netherlands, Russia, Slovakia, South Africa, Spain, Taiwan, Turkey and United Kingdom.
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.
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