Recall Z-0165-2015— Zimmer Surgical Inc

Class II FDA medical device recall by Zimmer Surgical Inc, initiated 2014-10-06, terminated 2015-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors 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.. Reason: Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected..

Recalling firm

Zimmer Surgical Inc

Classification

Class II

Status

Terminated

Initiated

2014-10-06

Terminated

2015-04-15

Firm location

Dover, OH, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.