Skeletal Kinetics recalls CRANIOSCULPT FLOW 5CC bone filler kits that may not maintain setting characteristics, risking longer surgery or poor bone healing. Affected products have specific product numbers and lot numbers.
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 is recalling CRANIOSCULPT FLOW 5CC bone filler kits because they may not stay set for the labeled time. This could lead to longer surgery, incomplete bone healing, or complications like nonunion.
The bone filler may not maintain its setting properties over time, which can cause longer surgical procedures. This might lead to incomplete bone healing, delayed union, or nonunion of the bone.
Patients who received the CRANIOSCULPT FLOW 5CC bone filler kit during surgery are most at risk. The product is used for filling bone gaps in extremities, spine, or pelvis after surgery.
Check for product number C-FLOW5CC-CAN and unique device identifier 813845020344. The affected kits were sold with lot numbers 17100405 and 1129762.
Look for product number C-FLOW5CC-CAN and unique device identifier 813845020344 on the kit.
The bone filler may not maintain its setting characteristics for the labeled shelf-life, which could increase surgery time or cause incomplete bone healing.
Possible risks include longer surgery, incomplete bone formation, delayed bone union, or nonunion of the bone.
Check for product number C-FLOW5CC-CAN and unique device identifier 813845020344. Affected kits have lot numbers 17100405 or 1129762.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2602-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2602-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
