UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of

FDA device recall Z-0165-2015 · posted 2014-10-31 · Terminated

Recall details

Recalling firm

Zimmer Surgical Inc

Reason for recall

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.

Action taken

Zimmer sent an Urgent Medical Device Correction letter via email to US distributors with traceable Fed Ex mailings to all consignees dated October, 2014. The letter identified the affected product, problem and actions to be taken. Customers were advised of the potential malfunction and the operating procedure for the handpiece per the Instructions for Use (IFU). Zimmer Surgical, as the importer, will provide notice to consignees in the US accordingly. In addition, units will receive an upgrade as part of the annual preventive maintenance per the Instructions for Use.

Root cause

Device Design

Status

Terminated

Product code

HAB

Quantity affected

828

Distribution

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.

Date initiated

2014-10-06

Date posted

2014-10-31

Date terminated

2015-04-15

Location

Dover, OH