Reported May 17, 2017 · Terminated

Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean"…

Greatbatch Medical

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: Greatbatch Medical · 2300 Berkshire Ln N · Plymouth, MN · 55441-4575

Is this the product you have?

  • Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).
Lot codes and dates
  • Lot numbersLinear
  • Straight Broach Handle (Rasp Handle)
    • 2988946
    • 3138186
    • 3185601
    • 3287315
    • 3300879
    • 3333172
    • 3433392
    • 3332697. EZ Clean"
  • Linear Broach Handle3508491
Amount recalled
205

Where it was sold

Why it was recalled

Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" Linear Broach Handle. Greatbatch Medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Greatbatch Medical recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 7, 2019 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.