Recall Z-0165-2015 ยท HAB Saw, Powered, And Accessories
Zimmer Surgical Inc
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 devic
| Date | Oct 31, 2014 (initiated Oct 6, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.