FDA-Device2013-09-04Class II
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Waldemar Link GmbH & Co. KG (Corp. Hq.)
Hazard
The trial stems were manufactured using the wrong design.
Sold states
US Distribution to the state of Tennessee only.
Affected count
5 units
Manufactured in
Barkausenweg 10, Hamburg, Germany
Products
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2063-2013Don't want to check this manually?
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