# FDA recall Z-2548-2018

> **Cayenne Medical Inc.** · Class II · device recall initiated 2010-04-28.

## Product

AperFix Femoral Implant Coring Removal Drill, labeled as the following:      a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109;    b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110;    c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111;    d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129;    e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130;    f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131;     Orthopedic surgical instrument.

## Reason for recall

A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.

## Distribution

Worldwide distribution.  US nationwide, Denmark, Finland, Malaysia, Netherlands, Poland, Switzerland, and Turkey.

## Key facts

- **Recall number:** Z-2548-2018
- **Recalling firm:** Cayenne Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2010-04-28
- **Report date:** 2018-08-01
- **Termination date:** 2019-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Scottsdale, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2548-2018

## Citation

> AI Analytics. FDA recall Z-2548-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2548-2018. Source: US FDA. Licensed CC0.

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