FDADecember 7, 2018device

LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly. The correct fit of the neck can't be verified by means of the guide rod.

What to do

FDA enforcement status: Terminated

Brands named

waldemar link gmbh co kg mfg sitewaldemarwaldemar link

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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