—#161212

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.

FDA product code: OLC — Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Serial/Lot Number(s) Affected: 4600: 15J456; 4601: 16A463, 16G470, 17F510; 4607: 16A461, 16D465, 16E467, 16F468, 17E506, 17E507; 4612: 16A458, 16A459, 17D489, 17E503, 17E504

Why it was recalled

The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Stryker Corporation
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: Netherlands

Timeline

Recall initiated: 2018-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161212. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.