Recall Z-0953-04 ยท GFF Bur, Surgical, General & Plastic Surgery
Medtronic Xomed, Inc.
Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070
| Date | Jul 20, 2004 (initiated Jan 29, 2004) |
| Status | Terminated |
| Reason | The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees. |
| Root cause | Other |
| Action | A Recall notification letter was mailed to each hospital account on January 29, 2004 for each type of device they received which was under recall explaining the error and asking the accounts to remove recalled product from inventory, fax them the response sheet and to return the products. |
| Quantity | 8 boxes 3 burs per box |
| Distribution | Products were distributed to 23 hospitals and surgical centers in NC, NB, IN, UT, TX, NY, WI, MO, TN, ID, OK, FL, MA, WY, NJ, LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.