FDA-Device2017-02-08Class II
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
Synthes (USA) Products LLC
Hazard
There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
Sold states
United States Nationwide Distribution.
Affected count
50,311 units
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1124-2017Don't want to check this manually?
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