Stryker Corporation recalls CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI

Recalled March 21, 2018 · FDA recall Z-0974-2018 · Stryker

Hazard

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

Units

155 devices

Sold at

Netherlands

Description

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

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.

Manufacturer(s)

Stryker Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →