RegWardenFDA facility compliance records
Recall

Class II — Zimmer, Inc.

Recalling firmZIMMER, INC.
Registered facilityView this company's 10 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThe firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
ProductZimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
Quantity87
DistributionUS 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.
Initiated2015-11-10
Classified2015-12-21
Terminated2016-02-19
Recall numberZ-0452-2016
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Zimmer, Inc. (Z-0452-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72688/

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