# FDA recall Z-1379-2021

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2021-03-05.

## Product

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 TS Trial Cutting Guide Size 1 Left  I-K3834CG1R     	Specialty Triathlon TS Trial Cutting Guide Size 1 Right  I-K3834CG2L      	Specialty Triathlon TS Trial Cutting Guide Size 2 Left  I-K3834CG2R     	Specialty Triathlon TS Trial Cutting Guide Size 2 Right  I-K3834CG3L      	Specialty Triathlon TS Trial Cutting Guide Size 3 Left  I-K3834CG3R     	Specialty Triathlon TS Trial Cutting Guide Size 3 Right  I-K3834CG4L      	Specialty Triathlon TS Trial Cutting Guide Size 4 Left  I-K3834CG4R     	Specialty Triathlon TS Trial Cutting Guide Size 4 Right  I-K3834CG5L      	Specialty Triathlon TS Trial Cutting Guide Size 5 Left  I-K3834CG5R     	Specialty Triathlon TS Trial Cutting Gu

## Reason for recall

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.

## Distribution

Distribution in US to: CA,, GA, NC, NJ, NV, OK, TX, and to Canada

## Key facts

- **Recall number:** Z-1379-2021
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-05
- **Report date:** 2021-04-14
- **Termination date:** 2024-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1379-2021

## Citation

> AI Analytics. FDA recall Z-1379-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1379-2021. Source: US FDA. Licensed CC0.

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