Home / Recalls / Medtronic Xomed, Inc. / Z-1934-2013

Z-1934-2013 Class II Terminated

Recalled by Medtronic Xomed, Inc. — Jacksonville, FL

FDA device recall Z-1934-2013 was initiated by Medtronic Xomed, Inc. on Jul 9, 2013 and is designated Class II. Reason for recall: The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY" The recall status is terminated (terminated Sep 25, 2014). Affected quantity: 3,562 trays.

Recall Details

Product Type: Devices
Report Date: Aug 21, 2013
Initiation Date: Jul 9, 2013
Termination Date: Sep 25, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,562 trays

Product Description

Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.

Reason for Recall

The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY"

Distribution Pattern

Worldwide Distribution - USA (nationwide) Nationwide, Hawaii, Puerto Rico and Guam. Internationally to: Canada, Austria, Belgium, Cyprus, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Morocco, Netherlands, Nigeria, Portugal, Qatar, Reunion, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Australia, New Zealand, Singapore, Thailand, Vietnam, China, Hong Kong,Taiwan, Korea, Japan, Brazil, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, and Venezuela.

Code Information

ALL Lots of the following models: Model 3717000 = 2 Level Instrument tray Model 3717001 = 3 Level tray (metal & radel) Model 3717006 = 2 Level Instruument tray with mat Model 3717026 = House Otology Set tray Model 3722301 = Wiet Chronic Ear Set tray Model 3747108 = Skykes Endobrow Lift tray Model 960374 = framelock tray Model *960-811 = Framelock Instrument set (includes tray 9603740 Model 960-619 = LandmarX tray Model *9731372XOM1 = Passive ENT Instrument Set (w/tray 960-619) Model MCOH0SC = Otology Plastic instrument tray Model MCO649SC = Middle Ear Instrument tray Model MCOS10SC = Instrument tray 2 level Model MCLS28 = MF Sataloff Complete Instrument tray Model MCLS37 = Sataloff Picks/Handles/Neddles Instrument tray Model 3319005 = Powerforma Bur Rack tray * instrument set that includes the identified tray

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1934-2013
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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