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.
This recall has been terminated (originally issued December 2, 2011).
- Company
- Synthes Usa (Hq), Inc.
- Recall Initiated
- October 17, 2011
- Posted
- December 2, 2011
- Terminated
- December 18, 2014
- Recall Number
- Z-0348-2012
- Quantity
- 5
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution including the states of CO, LA, NY, and OK.
Lot / Code Info
Catalog number: 532.026 - All lots
Root Cause
Device Design
Action Taken
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.