Z-0662-03

Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is...

Name: Z-0662-03 Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is...
Creator: Medtronic Xomed, Inc.
Published: 2002-01-25
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2002-01-25 / Terminated / root cause: packaging

FDA source

Medtronic Xomed, Inc. began a recall of Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar... on 2002-01-25. The reason FDA records is "Product packaging pouches may be open thereby compomising the sterile barrier". 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-0662-03
Status: Terminated
Initiated: 2002-01-25
Posted: 2003-03-20
Terminated: 2012-07-13
Recalling firm: Medtronic Xomed, Inc.
Product: Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows: Part Number 31-55631 Oto-Flex carbide 1.0mm Bur; Part Number 31-55632 Oto-Flex carbide 2.3mm Bur; Part Number 31-55642 Oto-Flex diamond 2.3mm Bur; Part Number 31-55647 Oto-Flex diamone 0.7 mm Bur PART NUMBER AND LOT NUMBER IS LISTED ON POUCH AND BOX LABEL.
Product code: EQJ Bur, Ear, Nose And Throat
Reason for recall: Product packaging pouches may be open thereby compomising the sterile barrier.
Root cause tag: packaging
FDA root cause: Other
Action: A recall notification letter and Effectiveness Response Form were Federal Expressed Overnight Delivery to the attention of the Risk Manager at each consignee on 1/25/2003. Consignees were requested to respond and return recalled product to Medtronic Xomed in Jacksonville, FL. or they can destroy them and request credit.
Quantity in commerce: 120
Distribution: Product was distributed to hospitals in the follwoing US states: CO, VA, MA, CA, HI, ID, VT, NY, NC, OK, MO, TX, GA, AND AL. there were no military or government accounts. There were nine international accounts as follows (all distributors): 1- Kir-Op AS, Biskop Jens Nilssonsgt 5A, Postal Box 6631 Etterstad 0607 Oslo, Norway. 2- Kebo Care Dema, Jerholmen 41, DK 2650 Hvidovre Denmark 3- Biomedical Technology, Via Tolstoi 7, 20090 Trezzano Sul, Nabiglio, Milan Italy. 4-Apex Medical Est. Jawad Sikkarieh Bldg., Sweifeh Amman 111121, PO Box 213131 Jordan 5- Diseven, Carrera 12 No 102-07 Santafe de Bogota Colombia; 6- Wise Horse, 10F-1 No. 11, Minchuan, Taipei, Taiwan 7- Medtronic Xomed, Unit 2/446 Victoria Road, Gladesville NSW Australia 8- Medtronic Xomed France, Saint Aubin Le Monial, 03160 Bourbon L''Archambault France 9- Medtroni BV Earl Bakenstraat 10, 6422 P J Heerlen, PO BNox 25880 6401 Db Heerlen, The Netherlands
Product codes and lots: Part No. 31-55631, lot number 27066500 Part No. 31-55632, lot number 27111700 Part No. 31-55642, lot number 27135800 Part No. 31-55647, lot number 27123300

Product code EQJ

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)