FDA-Device2013-10-02Class II
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Medtronic Xomed, Inc.
Hazard
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Sold states
Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
Affected count
60
Manufactured in
6743 Southpoint Dr N, N/A, Jacksonville, FL, United States
Products
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2284-2013Don't want to check this manually?
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