Skeletal Kinetics recalls CRANIOSCULPT FLOW 3CC bone filler kits that may not maintain setting characteristics, risking longer surgery or poor bone healing. Affected units have specific 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 3CC bone filler kits because they may not set properly over time. This could lead to longer surgeries, incomplete bone healing, or complications like nonunion. Consumers should check their product lot numbers to see if they are affected.
The bone filler may not maintain its setting characteristics for the labeled shelf life, which could cause longer surgical times or incomplete bone healing. This might result in issues like delayed union or nonunion of the bone.
Patients who have undergone bone surgery using the recalled CRANIOSCULPT FLOW 3CC kits are most at risk. This product is used for filling bone voids in extremities, spine, pelvis, or traumatic injuries.
Check the product lot numbers: 1126453, 1129759, 1140045, or 1141823. The product is a 3CC bone void filler kit sold under the brand Skeletal Kinetics.
Look for lot numbers 1126453, 1129759, 1140045, or 1141823 on the CRANIOSCULPT FLOW 3CC kit.
The recall indicates the product may not maintain setting characteristics, which could lead to longer surgery or poor bone healing. It is not recommended for use without checking the recall.
Check the product lot numbers to see if you are affected. If you have the recalled lot numbers, contact Skeletal Kinetics for further instructions.
The recall does not specify a remedy, so the product should be checked for lot numbers. If you have the affected lot numbers, you should stop using it and contact Skeletal Kinetics.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2600-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2600-2020 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.
