Z-2879-2011

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

Name: Z-2879-2011 Arthrex Reciprocating Saw Attachment Type: V-600SR Distributed by: Arthrex Inc., Naples, Florida United...
Creator: W & H DentalWerk Buermoos GMBH
Published: 2011-05-24
License: https://open.fda.gov/license/

W & H DentalWerk Buermoos GmbH / initiated 2011-05-24 / Terminated / root cause: manufacturing process

FDA source

W & H DentalWerk Buermoos GMBH began a recall of Arthrex Reciprocating Saw Attachment Type: V-600SR Distributed by: Arthrex Inc., Naples, Florida United States The system Is a modular electric system... on 2011-05-24. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2879-2011
Status: Terminated
Initiated: 2011-05-24
Posted: 2011-07-25
Terminated: 2015-10-09
Recalling firm: W & H DentalWerk Buermoos GmbH
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
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
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.
Root cause tag: manufacturing process
FDA root cause: 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: [email protected].
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.
Product codes and lots: Serial Numbers: 1106 through1310

Product code HWE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)