Cartiva Synthetic Cartilage Implant
Brand(s)
Last updated
Summary
Product
Cartiva Synthetic Cartilage Implant
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Cartiva Synthetic Cartilage Implant | All lots. | CAR-06 CAR-10 CAR-08 CMC-08 |
Issue
Stryker has become aware of recently published data and post market reports indicating that patients implanted with Cartiva SCI may experience a higher-than- expected occurrence rate when compared to data submitted in the 2016 PMA of the following documented hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation. Cartiva SCI devices have been observed in some cases to be revised/removed at higher rates than previously observed in the initial Cartiva SCI premarket and post-approval studies.
Recall start date: October 31, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies
| Cartiva, Inc. |
| 6120 Windward Parkway, Alpharetta, Georgia, United States, 30005 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76500
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