Z-0974-2018 Class II Ongoing
FDA device recall Z-0974-2018 was initiated by Stryker Corporation on Jan 25, 2018 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 155 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 21, 2018
- Initiation Date
- Jan 25, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 155 devices
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.
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 Pattern
Netherlands
Code Information
Serial/Lot Number(s) Affected: 4600: 15J456; 4601: 16A463, 16G470, 17F510; 4607: 16A461, 16D465, 16E467, 16F468, 17E506, 17E507; 4612: 16A458, 16A459, 17D489, 17E503, 17E504
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0974-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026