Z-1278-2013Class II

DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are...

Name: Z-1278-2013 DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are...
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2013-04-15
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2013-04-15 / Terminated / root cause: manufacturing process

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during... on 2013-04-15. FDA classified it as Class II and gives the reason as "Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1278-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-15
Posted: 2013-05-09
Terminated: 2016-03-11
Recalling firm: DePuy Mitek, Inc.
Product: DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.
Product code: NBH Accessories, Arthroscopic
Reason for recall: Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DePuy Synthes sent an Urgent Voluntary Product Recall letter dated April 15, 2013, to all affected customers. The letter iidentified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check all inventories to locate and return the affected product. For returns customers were instructed call 1-877-379-4871 to obtain a goods authorization (RGA) number. Affected product should be returned to: Mitek Sports Medicine ATTN: Mitek Complaints 325 Paramouont Drive Rayham, MA 02067 For questions customers were instructed to call 1-877-379-4871.
Quantity in commerce: 27 units
Distribution: Worldwide Distribution - USA including KY, NJ and Internationally to Argnetina, Australia, Belgium,Columbia, India, France, Japan, Jordan, Latvija, Israel, Korea, and Great Britain. For questions regarding this recall call 508-977-3813.
Product codes and lots: Lot number:13A01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1278-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1278-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-09

Product code NBH

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)