CLASS II Device recall · Reported 15 May 2013 · FDA Enforcement Report

DePuy Mitek Tissue Liberator -Blade Up recalled

DePuy Mitek, Inc., a Johnson & Johnson is recalling DePuy Mitek Tissue Liberator -Blade Up, distributed in Kentucky, New Jersey. The recall was initiated on 15 Apr 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number:13A01

Quantity recalled27 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1278-2013
FDA event ID: 64913
Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 15 Apr 2013
FDA classified: 9 May 2013
Reported: 15 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

15 Apr 2013	Recall initiated by company
9 May 2013	Classified by FDA	+24 days
15 May 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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.

Kentucky New Jersey

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot number:13A01

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from DePuy Mitek, Inc., a Johnson & Johnson

All 51

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025Device	CLASS II	COR Disposable Kit w/ Perpendicularity recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
19 Mar 2025Device	CLASS II	COR Disposable Kit Cartilage Transplant System recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Rapid w/ Pan-Indicated for use recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Plus w/ Ethibond-Iindicated recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Rapid W/ OC-Indicated for use recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide

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