FDAJanuary 12, 2018device
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
What to do
FDA enforcement status: Terminated
Brands named
howmedica osteonicshowmedica
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDATRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.2026-05-19
- FDATRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.2026-05-19
- FDAMICS3 Angled Sagittal Saw Attachment; Part Number: 2104902026-02-02
- FDAThe Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in...2025-11-12
- 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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