Devices

Device Recall Collagen Meniscus Implant

Model / Serial
Serial/Lot Number(s) Affected: 4600: 15J456; 4601: 16A463, 16G470, 17F510; 4607: 16A461, 16D465, 16E467, 16F468, 17E506, 17E507; 4612: 16A458, 16A459, 17D489, 17E503, 17E504
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Netherlands
Product Description
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
Stryker Corporation
1 Event
- Recall of Device Recall Collagen Meniscus Implant

Manufacturer

Stryker Corporation

Manufacturer Address
Stryker Corporation, 5900 Optical Ct, San Jose CA 95138-1400
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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