DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut th

FDA device recall Z-0529-2013 · posted 2012-12-17 · Terminated

Recall details

Recalling firm

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

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

Action taken

DePuy Mitek sent an Urgent Voluntary Product Recall letter dated November 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to refer to the attached instructions to report their inventory status and for returning the affected product. Customers with questions should call 1-508-880-8477. For questions regarding this recall call 508-880-8100.

Root cause

Packaging process control

Status

Terminated

Product code

HTO

Quantity affected

20

Distribution

Nationwide Distribution including IL and NJ

Date initiated

2012-11-16

Date posted

2012-12-17

Date terminated

2012-12-21

Location

Raynham, MA