FDA-Device2013-09-04Class II
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 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
6 units
Manufactured in
Barkausenweg 10, Hamburg, Germany
Products
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2067-2013Don't want to check this manually?
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