Recall Z-2284-2013 ยท ETA Replacement, Ossicular Prosthesis, Total
Medtronic Xomed, Inc.
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
| Date | Sep 26, 2013 (initiated Aug 23, 2013) |
| Status | Terminated |
| Reason | One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 60 |
| Distribution | Nationwide Distribution (US), including the states of CA, NE, GA, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002897 | TITANIUM MIDDLE EAR PROSTHESES Xomed, Inc., Oct 11, 2000 |