# FDA recall Z-2942-2020

> **MicroPort Orthopedics Inc.** · Class I · device recall initiated 2020-07-31.

## Product

PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256.  Hip prosthesis component

## Reason for recall

MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation.  Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States  there were 349 Long and X-Long PROFEMUR Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019.   There is an average time of 5.4 years to device fracture after implantation.

## Distribution

worldwide, except China and Japan

## Key facts

- **Recall number:** Z-2942-2020
- **Recalling firm:** MicroPort Orthopedics Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-31
- **Report date:** 2020-09-30
- **Termination date:** 2024-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Arlington, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2942-2020

## Citation

> AI Analytics. FDA recall Z-2942-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2942-2020. Source: US FDA. Licensed CC0.

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