Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
- Company
- Medtronic Xomed, Inc.
- Recall Initiated
- August 23, 2013
- Posted
- September 26, 2013
- Terminated
- November 7, 2013
- Recall Number
- Z-2284-2013
- Quantity
- 60
- Firm Location
- Jacksonville, FL
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.
Distribution
Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
Lot / Code Info
REF: 1150000 Lot: 0207029284
Root 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.
More recalls by Medtronic Xomed, Inc.
IPC Powerease System REF 2300000
UDI-DI:
00613994448705
00643169406834.
The IPC POWEREASE System is...
Aug 27, 2025
NIM Vital Nerve Monitoring System:
CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;
CONSOLE NIM4CM01RF NIM...
Apr 18, 2025