Arthrex Reciprocating Saw Attachment Type: V-600SR Distributed by: Arthrex Inc., Naples, Florida United States The syste

FDA device recall Z-2879-2011 · posted 2011-07-25 · Terminated

Recall details

Recalling firm

W & H DentalWerk Buermoos GMBH

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.

Action taken

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

HWE

Quantity affected

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, Sp

Date initiated

2011-05-24

Date posted

2011-07-25

Date terminated

2015-10-09

Location

Burmoos, Austria