FDAAugust 7, 2024device
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
What to do
FDA enforcement status: Ongoing
Brands named
howmedica osteonicshowmedica
UPCs
00848486030193
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
- FDACustom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;2024-08-05
- FDAUNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-0432024-06-19
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