FDA Device recall Z-0452-2016
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece by Zimmer, citing the firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0452-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-10 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | 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, WY |
Product
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
Reason
The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
Identifiers
| code_info | Model # 01-8507-400-00 & Model # 89-8507-400-00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0452-2016%22
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