Events

Recall of Device Recall Collagen Meniscus Implant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79030
  • Event Risk Class
    Class 2
  • Event Number
    Z-0974-2018
  • Event Initiated Date
    2018-01-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161212
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Scaffold, partial medial meniscal defects extending into the red/white zone, resorbable bovine collagen - Product Code OLC
  • Reason
    The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.
  • 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.

Device

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

Manufacturer

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