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U.S. Department of Health and Human Services

Class 2 Device Recall Collagen Meniscus Implant

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  Class 2 Device Recall Collagen Meniscus Implant see related information
Date Initiated by Firm January 25, 2018
Create Date March 12, 2018
Recall Status1 Open3, Classified
Recall Number Z-0974-2018
Recall Event ID 79030
Product Classification Scaffold, partial medial meniscal defects extending into the red/white zone, resorbable bovine collagen - Product Code OLC
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.
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
Recalling Firm/
Manufacturer		 Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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