# FDA recall Z-1005-2019

> **Zimmer Trabecular Metal Technology, Inc.** · Class II · device recall initiated 2019-02-01.

## Product

NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial,  Size 4 5MM Thickness W/Screws  Item Number: 00544800426    Product Usage:  The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.

## Reason for recall

Potentially comingled, resulting in the product in the box potentially not matching the product on the label

## Distribution

Worldwide Distribution - US Nationwide Distribution in the states of AL, CA, CO, ID, MS,NE, NJ, NY, OH, OR, PA, TX, VA, WI and Foreign CANADA, JAPAN,   GERMANY ,  NETHERLANDS

## Key facts

- **Recall number:** Z-1005-2019
- **Recalling firm:** Zimmer Trabecular Metal Technology, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-01
- **Report date:** 2019-03-20
- **Termination date:** 2020-05-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1005-2019

## Citation

> AI Analytics. FDA recall Z-1005-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1005-2019. Source: US FDA. Licensed CC0.

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