Class 2 Device Recall Cartiva

• Date Initiated by Firm: October 31, 2024
• Date Posted: December 04, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0598-2025
• Recall Event ID: 95661
• PMA Number: P150017
• Product Classification: Prosthesis, metatarsophalangeal joint cartilage replacement implant - Product Code PNW
• Product: Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
• Code Information: 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.
• Recalling Firm/ Manufacturer: Cartiva, Inc; 6120 Windward Pkwy Ste 220; Alpharetta GA 30005-4185
• For Additional Information Contact: Meghan Wells; 901-201-9298
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: 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.
• 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.
• 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.

• PMA Database: PMAs with Product Code = PNW