FDANovember 7, 2022device
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
What to do
FDA enforcement status: Ongoing
Brands named
howmedica osteonicshowmedica
UPCs
07613327128772
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDACustom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;2024-08-05
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