Reported Nov 12, 2014 · Terminated

UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of…

Zimmer Surgical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Surgical Inc · 200 W Ohio Ave · Dover, OH · 44622-9642

Is this the product you have?

  • UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box
  • Product UsageSurgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade
Lot codes and dates
  • 89-8507-400-00 - UNIVERSAL Modular Electric/Battery Double Trigger Handpiece 89-8507-400-10 - UNIVERSAL Modular Electric/Battery Single Trigger Handpiece

    1,279 of 1,279 codes

    • 222805
    • 222806
    • 222807
    • 222808
    • 222809
    • 222810
    • 222811
    • 222812
    • 222813
    • 222814
    • 222945
    • 222946
    • 222947
    • 222948
    • 222949
    • 222950
    • 222951
    • 222952
    • 222953
    • 222955
    • 222956
    • 223077
    • 223078
    • 223079
    • 223080
    • 223081
    • 223082
    • 223083
    • 223084
    • 223085
    • 223086
    • 223199
    • 223200
    • 223201
    • 223202
    • 223203
    • 223204
    • 223205
    • 223206
    • 223207
    • 223208
    • 223209
    • 223210
    • 223401
    • 223403
    • 223404
    • 223405
    • 223406
    • 223407
    • 223408
    • 223409
    • 223410
    • 223411
    • 223730
    • 223731
    • 223732
    • 223733
    • 223734
    • 223735
    • 223736
Amount recalled
828

Where it was sold

Why it was recalled

Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 15, 2015 · Data as of Sep 19, 4:45 PM UTC

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