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Synthes (USA) Products LLC recalls Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primar
Recalled February 8, 2017 · FDA recall Z-1124-2017 · Synthes (USA) Products
Hazard
There is the possibility that the radial stem may loosen post-operatively at the stem bone interface. · FDA Class II
Units
50,311 units
Sold at
United States Nationwide Distribution.
Description
There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
Product
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →