Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
This recall is currently active, issued December 4, 2024. It was issued by Cartiva, Inc.
- Company
- Cartiva, Inc
- Recall Initiated
- October 31, 2024
- Posted
- December 4, 2024
- Recall Number
- Z-0598-2025
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation.
Distribution
Worldwide - US Nationwide distribution in the states of CO, CT, FL, IL, MI, MS, NY, OH, RI, UT, VA, AL, AR, AZ, CA, IA, ID, IN, KS, KY, MA, MN, MO, MT, NC, NE, NM, NV, OK, OR, PA, TN, TX, WA, WI and the countries of Australia, Austria, Brazil, Canada, Chile, Cyprus, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Kuwait, Latvia, Lebanon, Netherlands, New Zealand, Panama, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Lot / Code Info
Catalog/UDI-DI: CAR-06-US/00852897002328, CAR-08-US/00852897002021, CAR-10-US/ 00852897002038, CAR-12-US/00852897002335. All lots Distributed from July 2016 to October 2024.
Root Cause
Device Design
Action Taken
On 10/31/24 recall notices were mailed or emailed to customers asking them to do the following: 1) Continue to follow patients treated with an impacted product for new or worsening symptoms of pain, difficulty walking, skin reactions, stiffness, swelling, or weakness of the big toe joint, consistent with your follow up protocols. Per Instructions for Use: the long-term effects of cartilage replacement are not known; and the clinical and medical status of each patient should be considered when treating patients. 2) To help minimize complications, reference the information in the Instructions for Use and the information included in this notification. Per standard practice, continue to discuss all potential risks identified and discuss the benefits and risks of all relevant treatment options for first metatarsophalangeal joint osteoarthritis with your patients. 3) Check your internal inventory to locate the products listed on the attached business reply form, remove them from their point of use, isolate/quarantine the unit(s), and return. 4) Share and maintain awareness of this communication in your practice with until all required actions have been completed within your facility. 5) If you have further distributed the affected product, please notify the applicable parties about this notice. You may copy and distribute this notification letter. 6) If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately. 7) If you are a distributor, note that you are responsible for notifying your affected customers. 8) Complete and return the response form via email to fieldaction@stryker.com For questions or concerns, contact fieldaction@stryker.com.