PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 15, 2013 Initiated: April 15, 2013 #Z-1278-2013

Product Description

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.

Reason for Recall

Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.

Details

Units Affected
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.
Location
Raynham, MA

Frequently Asked Questions

What product was recalled?
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.. Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co.. Units affected: 27 units.
Why was this product recalled?
Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 15, 2013. Severity: Moderate. Recall number: Z-1278-2013.