Skeletal Kinetics recalls CRANIOSCULPT FLOW 10CC bone filler kits that may not maintain setting characteristics, risking longer surgery or poor bone healing. Affected units include 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 10CC bone filler kits because they may not stay set for the labeled time. This could lead to longer surgeries, incomplete bone healing, or complications like nonunion.
The bone filler may not maintain its set structure for the full shelf life, causing it to fail during healing. This could lead to longer surgical times, incomplete bone formation, or complications like delayed healing or nonunion.
Patients who received the CRANIOSCULPT FLOW 10CC bone filler kit 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-FLOW10CC-OUS and unique identifier 813845020382. Affected units include specific lot numbers: 17100410, 1127978, 1139621, 1140042.
Identify the product number C-FLOW10CC-OUS and unique identifier 813845020382 to confirm if your kit is affected.
The bone filler may not maintain its setting characteristics for the labeled shelf-life, which could lead to longer surgery times or poor bone healing.
Affected lot numbers are 17100410, 1127978, 1139621, and 1140042.
The recall record does not specify a remedy, so affected users should contact Skeletal Kinetics for guidance.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2603-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2603-2020 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.
