# FDA recall Z-1462-2018

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2018-01-30.

## Product

Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601    The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.

## Reason for recall

Customers may receive  the incorrect size implant from what is labeled on the box.

## Distribution

USA (nationwide) Distribution to the states of : AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA

## Key facts

- **Recall number:** Z-1462-2018
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-30
- **Report date:** 2018-05-02
- **Termination date:** 2020-05-07

- **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-1462-2018

## Citation

> AI Analytics. FDA recall Z-1462-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1462-2018. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*