CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant ...
FDA Device Recall #Z-0974-2018 — Class II — January 25, 2018
Recall Summary
| Recall Number | Z-0974-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 25, 2018 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Corporation |
| Location | San Jose, CA |
| Product Type | Devices |
| 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
Lot / 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
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|---|---|---|---|
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| Z-0601-2026 | Class II | NICO BrainPath; Product Number/Product Name ... | Oct 31, 2025 |
| Z-0599-2026 | Class II | NICO Myriad Handpiece Product Number/Product... | Oct 31, 2025 |
| Z-0600-2026 | Class II | NICO Myriad Illumination Pack Product No. NN... | Oct 31, 2025 |
| Z-2277-2025 | Class II | Stryker SmartPump Tourniquet, disposable steril... | Jul 2, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.