Z-0453-2016 Class II Terminated
FDA device recall Z-0453-2016 was initiated by Zimmer, Inc. on Nov 10, 2015 and is designated Class II. Reason for recall: The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected. The recall status is terminated (terminated Feb 19, 2016). Affected quantity: 89 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 30, 2015
- Initiation Date
- Nov 10, 2015
- Termination Date
- Feb 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89 units
Product Description
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
Reason for Recall
The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
Distribution Pattern
US Distribution to the states of : AR, CA, CO, CT, FL, GA, HI, IL, KS, KY, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY.
Code Information
Model # 01-8507-400-10 & Model # 89-8507-400-10
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0453-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026