Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070
- Company
- Medtronic Xomed, Inc.
- Recall Initiated
- January 29, 2004
- Posted
- July 20, 2004
- Terminated
- May 3, 2012
- Recall Number
- Z-0953-04
- Quantity
- 8 boxes 3 burs per box
- Firm Location
- Jacksonville, FL
Reason for Recall
The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees.
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.
Lot / Code Info
Lot 26371200
Root Cause
Other
Action Taken
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.
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