Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery… — Class II medical device recall Z-0452-2016
Terminated recall by Zimmer, Inc., reported 2015-12-30, distributed in AR, CA, CO, CT, FL, GA, HI, IL…. The firm identified a malfunction which made it possible for a handpiece to start by itself when the power sou
| Recall number | Z-0452-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-11-10 |
| Classified | 2015-12-21 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-02-19 |
| Distributed | 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 |
| Quantity | 87 |
| Reason classes | device malfunction |
| Model numbers | 01-8507-400-00, 89-8507-400-00 |
Product
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0452-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.