# FDA recall Z-1186-2021

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2021-02-10.

## Product

Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.

## Reason for recall

Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate.  The taper prevents the insert from locking on the baseplate.

## Distribution

Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV.

## Key facts

- **Recall number:** Z-1186-2021
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-10
- **Report date:** 2021-03-17
- **Termination date:** 2023-05-30

- **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-1186-2021

## Citation

> AI Analytics. FDA recall Z-1186-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1186-2021. Source: US FDA. Licensed CC0.

---

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