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.

Enforcement

• Recall Number: Z-0529-2013
• Event ID: 63732
• Classification: Class II
• Status: Terminated
• Product Type: Devices
• Firm: DePuy Mitek, Inc., a Johnson & Johnson Co.
• Voluntary / Mandated: Voluntary: Firm initiated
• Initial Notification: Telephone
• Report Date: December 26, 2012
• Initiation Date: November 16, 2012
• Classification Date: December 17, 2012
• Termination Date: December 21, 2012
• Address: 325 Paramount Dr, Raynham, MA, 02767, United States

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

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

Code Info

Lot Number: 3611687

Distribution

Nationwide Distribution including IL and NJ

Quantity

20

Recall Classification

• Class II

Moderate — may cause temporary or medically reversible health consequences.

Firm

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

Raynham, MA, United States