# FDA recall Z-2949-2018

> **DePuy Orthopaedics, Inc.** · Class II · device recall initiated 2018-07-18.

## Product

P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830

## Reason for recall

This unit may be missing the screw/collet Assembly

## Distribution

The devices were not distributed in the United States.    The devices were distributed to the following foreign countries:  Great Britain.

## Key facts

- **Recall number:** Z-2949-2018
- **Recalling firm:** DePuy Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-18
- **Report date:** 2018-09-05
- **Termination date:** 2019-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2949-2018

## Citation

> AI Analytics. FDA recall Z-2949-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2949-2018. Source: US FDA. Licensed CC0.

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