FDAMay 28, 2015device

Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

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

The hazard

It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgical Technique Guide.

What to do

FDA enforcement status: Terminated

Brands named

synthes

Recall history

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

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