Recall Z-0974-2018— Stryker Corporation

Class II FDA medical device recall by Stryker Corporation, initiated 2018-01-25. FDA's recall record names no specific 510(k) clearance for this event. 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: The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit..

Recalling firm

Stryker Corporation

Classification

Class II

Status

Ongoing

Initiated

2018-01-25

Firm location

San Jose, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.