Reported Dec 26, 2012 · Terminated

DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut…

DePuy Mitek, Inc., a Johnson & Johnson Co.

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: DePuy Mitek, Inc., a Johnson & Johnson Co. · 325 Paramount Dr · Raynham, MA · 02767

Is this the product you have?

  • DePuy Mitek 11 MM Fully Fluted Reamer
  • Sterile Product Number232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee
Lot codes and dates
  • Lot Number3611687
Amount recalled
20

Where it was sold

Why it was recalled

Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer

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 Dec 21, 2012 · Data as of Sep 19, 4:50 PM UTC

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