Z-0348-2012

Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument motor and...

Name: Z-0348-2012 Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument motor and...
Creator: Synthes USA (HQ), Inc.
Published: 2011-10-17
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2011-10-17 / Terminated / root cause: design

FDA source

Synthes USA (HQ), Inc. began a recall of Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument motor and accessories are AC-powered, battery-powered or... on 2011-10-17. The reason FDA records is "The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece, there is a potential for injury to the patient and/or...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0348-2012
Status: Terminated
Initiated: 2011-10-17
Posted: 2011-12-02
Terminated: 2014-12-18
Recalling firm: Synthes GmbH
Product: Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for 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, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall: The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece, there is a potential for injury to the patient and/or user.
Root cause tag: design
FDA root cause: Device Design
Action: Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated October 17, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The firm requests that customers return their affected device(s) for servicing. Instructions are provided for customers to follow. Customers having questions regarding this notice should contact the firm at 610-719-5450.
Quantity in commerce: 5
Distribution: Nationwide Distribution including the states of CO, LA, NY, and OK.
Product codes and lots: Catalog number: 532.026 - All lots

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)