Z-0529-2013Class II

DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are...

Name: Z-0529-2013 DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are...
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2012-11-16
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2012-11-16 / Terminated / root cause: packaging

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone... on 2012-11-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0529-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-16
Posted: 2012-12-17
Terminated: 2012-12-21
Recalling firm: DePuy Mitek, Inc.
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.
Product code: HTO Reamer
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
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 20
Distribution: Nationwide Distribution including IL and NJ
Product codes and lots: Lot Number: 3611687

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0529-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0529-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-17

Product code HTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)