—#104849

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.

FDA product code: HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog number: 532.026 - All lots

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Synthes USA (HQ), Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Nationwide Distribution including the states of CO, LA, NY, and OK.

Timeline

Recall initiated: 2011-10-17
Posted by FDA: 2011-12-02
Terminated: 2014-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104849. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.