# FDA recall Z-0974-2018

> **Stryker Corporation** · Class II · device recall initiated 2018-01-25.

## Product

CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant    Product Usage:  The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.

## Reason for recall

The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.

## Distribution

Netherlands

## Key facts

- **Recall number:** Z-0974-2018
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-01-25
- **Report date:** 2018-03-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0974-2018

## Citation

> AI Analytics. FDA recall Z-0974-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0974-2018. Source: US FDA. Licensed CC0.

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