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Encore Medical, Lp recalls RSP Impaction Fixture
Recalled March 15, 2017 · FDA recall Z-1413-2017 · Encore Medical
Hazard
During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. · FDA Class II
Units
626 units
Sold at
US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
Description
During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.
Product
RSP Impaction Fixture
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →