FDAFDA · Food and drugs·Recall number Z-0529-2013
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.
Published December 26, 2012 · Recall initiated: November 16, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Distributor
- Nationwide Distribution including IL and NJ
- Lot
- Lot Number: 3611687
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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