Home / Recalls / Medical Devices
Medtronic Xomed, Inc. recalls Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated
Recalled October 2, 2013 · FDA recall Z-2284-2013 · Medtronic Xomed
Hazard
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft. · FDA Class II
Units
60
Sold at
Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
Description
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Product
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Manufacturer(s)
Medtronic Xomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →