DePuy Mitek, Inc., a Johnson & Johnson Co.: Medical Device Recall in 2012 - (Recall #: Z-0529-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 16, 2012

Date Posted: December 26, 2012

Recall Number: Z-0529-2013

Event ID: 63732

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

Status: Terminated

Product Quantity: 20

Code Information:

Lot Number: 3611687

Distribution Pattern:

Nationwide Distribution including IL and NJ

Voluntary or Mandated:

Voluntary: Firm initiated