FDAMarch 5, 2021device
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set I-K3834CG1L Specialty Triathlon...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery.
What to do
FDA enforcement status: Terminated
Brands named
howmedica osteonicshowmedica
UPCs
076133273275950761332732753307613327327748076133273292090761332732919307613327329100076133273290870761332732906307613327328899076133273288680761332732870707613327328691
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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