Z-0974-2018Class II

CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant

Name: Z-0974-2018 CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant
Creator: Stryker Corporation
Published: 2018-01-25
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2018-01-25 / Open, Classified / root cause: packaging

FDA source

Stryker Corporation began a recall of CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s... on 2018-01-25. FDA classified it as Class II and gives the reason as "The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0974-2018
Classification: Class II
Status: Open, Classified
Initiated: 2018-01-25
Posted: 2018-03-12
Recalling firm: Stryker Corp.
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.
Product code: OLC Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: The international Stryker site was notified by email on 1/25/2018. Customers are instructed to: 1. Inform individuals within your organization who need to be aware of this device removal. 2. Review Part Numbers (4600, 4601, 4607, and 4612) for affected lot numbers. Please determine if you have the affected product in stock. Response is required. 3. If no product is found, notify your local Stryker office.4. If you do have product, segregate the product and call your local Stryker office to arrange for product return and issuance of credit.
Quantity in commerce: 155 devices
Distribution: Netherlands
Product codes and lots: Serial/Lot Number(s) Affected: 4600: 15J456; 4601: 16A463, 16G470, 17F510; 4607: 16A461, 16D465, 16E467, 16F468, 17E506, 17E507; 4612: 16A458, 16A459, 17D489, 17E503, 17E504

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0974-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0974-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-03-21	2018-03-12

Product code OLC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)