The Recall Desk
HighFDA (Devices)·Z-0165-2015·Announced 2014-11-12

Zimmer Surgical Recalls Universal Modular Electric Handpieces Due to Malfunction

Zimmer Surgical Inc is recalling 828 Universal Modular Electric/Battery Handpieces because a malfunction allows them to start unexpectedly when connected to a power source.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (surgical handpiece) where injury has not yet been reported, which aligns with the 'High' severity criteria for theoretical hazards without confirmed illness or injury.

Plain-English summary

Zimmer Surgical Inc is recalling 828 units of the Universal Modular Electric/Battery Handpiece for surgery. The recall was initiated after non-injury complaints from Europe identified a malfunction that makes it possible for the handpiece to start by itself when the power source is connected.

The affected products are surgical instrument motors intended for use during surgical procedures to provide power to operate various accessories or attachments. The handpieces are packaged in a foam bag inside a padded-foam corrugate box with an operating manual. The recall covers units distributed nationwide in the United States, including specific states such as 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.

No injuries have been reported in connection with this recall. Users should stop using the affected handpieces and contact Zimmer Surgical Inc for further instructions on the recall.

The recalled product

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
Affected units
828

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically: