Recall Z-2284-2013
Medtronic Xomed, Inc. · initiated August 23, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Codes / lots: REF: 1150000 Lot: 0207029284
Reason for recall
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
FDA-determined cause: Process control
Action taken
An "URGENT PRODUCT RECALL" letter was faxed to customers following the initial telephone notification. The letter described the product issue and provided recommended actions. Questions were directed to customer service at 800-874-5797.
Details
- Recall number
- Z-2284-2013
- Initiated
- August 23, 2013
- Posted by FDA
- September 26, 2013
- Terminated
- November 7, 2013
- Product code
- ETA – Replacement, Ossicular Prosthesis, Total
- Quantity
- 60
- Distribution
- Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
- Recalling firm
- Medtronic Xomed, Inc., Jacksonville, FL