Reported Mar 21, 2018 · Ongoing
CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI…
Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Corporation · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
- CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based
- meniscus implant Product UsageThe 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 (GAGschondroitin 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
- Lot codes and dates
- Serial/Lot Number(s) Affected
4600: 15J4564601: 16A46316G47017F5104607: 16A46116D46516E46716F46817E50617E5074612: 16A45816A45917D48917E50317E504
- Serial/Lot Number(s) Affected
- Amount recalled
- 155 devices
Why it was recalled
The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.
This product could cause temporary or reversible health problems — stop using it.
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