Encore Medical, Lp recalls Turon Impaction Fixture
- Recall date
- February 9, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1412-2017
- FDA classification
- Class II
- Brand / firm
- Encore Medical, Lp
- Sold / distributed
- US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Turon Impaction Fixture
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