Skeletal Kinetics recalls CRANIOSCULPT FLOW 5CC products that may not maintain setting characteristics, increasing surgery time and risk of incomplete bone healing.
Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Skeletal Kinetics recalls CRANIOSCULPT FLOW 5CC bone void filler kits that may not set properly over time. This could lead to longer surgery, incomplete bone healing, or nonunion of bones after surgery.
The bone filler may not maintain its setting properties for the labeled shelf life. This could cause longer surgery times, incomplete bone healing, or nonunion of bones where the filler was placed.
Patients who received the recalled CRANIOSCULPT FLOW 5CC bone void filler kits during surgery are most at risk. The product is used for filling bone gaps in extremities, spine, or pelvis after trauma or surgery.
Check for product number C-FLOW5CC-OUS and unique device identifier (UDI) 813845020351. The recalled items were sold with lot numbers 17100406, 1126461, 1129956, and 1141820.
Verify the product number (C-FLOW5CC-OUS) and UDI (813845020351) to confirm if the item is recalled.
The product may not maintain its setting characteristics over time, which could increase surgery time or cause incomplete bone healing. It is not safe for use as intended without proper setting.
The official recall notice does not specify a remedy or action for affected products. Check with your healthcare provider for guidance.
Lot numbers 17100406, 1126461, 1129956, and 1141820 are affected.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2604-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2604-2020 from Skeletal Kinetics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
