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U.S. Department of Health and Human Services

Class 2 Device Recall Oto Flex Bur

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  Class 2 Device Recall Oto Flex Bur see related information
Date Initiated by Firm January 25, 2002
Date Posted March 20, 2003
Recall Status1 Terminated 3 on July 13, 2012
Recall Number Z-0662-03
Recall Event ID 25706
Product Classification Bur, Ear, Nose And Throat - Product Code EQJ
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.
Code Information 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
Recalling Firm/
Manufacturer		 Medtronic Xomed, Inc.
6743 Southpoint Dr, N.
Jacksonville FL 32216
For Additional Information Contact B.L. McDermott, RAC
800-874-5797
Manufacturer Reason
for Recall		 Product packaging pouches may be open thereby compomising the sterile barrier.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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