Zimmer Surgical Inc recalls UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside

Recalled November 12, 2014 · FDA recall Z-0165-2015 · Zimmer Surgical

Hazard

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. · FDA Class II

Units

828

Sold at

US Nationwide Distribution in the states of: AK, AL,AR, AZ,CA,CO,CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA,ME, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY.

Description

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.

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.

Manufacturer(s)

Zimmer Surgical Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →