RecallRadar

FDA Device recall Z-0452-2016

Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece

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

AgencyFDA Device
Recall numberZ-0452-2016
ClassificationClass II
Statusterminated
Initiated2015-11-10
Published2015-12-30
Last updated2026-09-13 11:53 UTC
CompanyZimmer
DistributionAR, 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_infoModel # 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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