Recall Z-0529-2013— DePuy Mitek, Inc., a Johnson & Johnson Co.
Class II · Terminated
Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2012-11-16, terminated 2012-12-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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.
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-16
- Terminated
- 2012-12-21
- Firm location
- Raynham, MA, United States
Product description
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.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.