FDAFebruary 27, 2024device
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
What to do
FDA enforcement status: Ongoing
Brands named
howmedica osteonicshowmedica
UPCs
07613327380897
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDA1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;2025-08-28
- FDATriathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-2002024-09-04
- FDAMAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 2090632024-08-07
- 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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