Skeletal Kinetics recalls CRANIOSCULPT FLOW 10CC bone void filler kits that may not maintain setting characteristics, risking longer surgery times or 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 is recalling CRANIOSCULPT FLOW 10CC bone void filler kits because they may not stay set for the labeled time. This could lead to longer surgeries, incomplete bone healing, or other complications.
The bone void filler may not maintain its setting characteristics over time, which can lead to longer surgical procedures. This risk could cause incomplete bone healing, delayed union, or nonunion of the bone.
Patients who have received the CRANIOSCULPT FLOW 10CC bone void filler kit during surgery are most at risk. The product is used for filling bone gaps in surgeries.
Check for the product name 'CRANIOSCULPT FLOW', 10CC can, Product Number C-FLOW10CC-CAN, and UDI 813845020375. The kit was sold with Lot Number 17100409.
Look for the product name 'CRANIOSCULPT FLOW', 10CC can, Product Number C-FLOW10CC-CAN, and UDI 813845020375.
CRANIOSCULPT FLOW 10CC bone void filler kits with Product Number C-FLOW10CC-CAN and UDI 813845020375.
The bone void filler may not maintain its setting characteristics for the labeled shelf-life, which could lead to longer surgeries or incomplete bone healing.
The recall record does not specify a remedy, so check with Skeletal Kinetics for further instructions.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2632-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2632-2020 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.
