Recall Z-0662-03 ยท EQJ Bur, Ear, Nose And Throat
Medtronic Xomed, Inc.
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 L
| Date | Mar 20, 2003 (initiated Jan 25, 2002) |
| Status | Terminated |
| Reason | Product packaging pouches may be open thereby compomising the sterile barrier. |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.