FDA-Device2017-03-15Class II
RSP Impaction Fixture
Encore Medical, Lp
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.
Sold states
US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
Affected count
626 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
RSP Impaction Fixture
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1413-2017Don't want to check this manually?
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