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.
FDA Recall Z-0165-2015 · Posted 2014-10-31
Recalling FirmZimmer Surgical Inc
Recall StatusTerminated
Product CodeHAB
Date Initiated2014-10-06
Date Terminated2015-04-15
Product Quantity828
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.
Firm Action
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
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.