FDA-Device2012-12-26Class II
DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.
DePuy Mitek, Inc., a Johnson & Johnson Co.
Hazard
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
Sold states
Nationwide Distribution including IL and NJ
Affected count
20
Manufactured in
325 Paramount Dr, Raynham, MA, United States
Products
DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0529-2013Don't want to check this manually?
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