Skeletal Kinetics recalls CRANIOSCULPT FLOW 5CC bone 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 5CC bone filler kits because they may not stay set for the labeled time. This could lead to longer surgeries or improper bone healing.
The bone filler kits may not maintain their setting properties over time, which can cause longer surgical procedures or incomplete bone healing. This might result in delayed bone union or nonunion of the bone.
Patients who received the recalled CRANIOSCULPT FLOW 5CC kits for bone void filling during surgery are most at risk. The product is used in specific surgical procedures for bone gaps.
Check for product number C-FLOW5CC and unique device identifier 813845020337. The recalled kits were sold with lot numbers 1129763, 1137730, 1141819, and 1144572.
Verify the product number (C-FLOW5CC) and unique device identifier (813845020337) to confirm if your kit is recalled.
The CRANIOSCULPT FLOW 5CC bone filler kits may not maintain their setting characteristics for the labeled shelf-life, which could lead to longer surgery times or incomplete bone healing.
Using the recalled kits may increase surgical and anesthesia time, or cause incomplete bone formation, delayed union, or nonunion of the bone.
Check for product number C-FLOW5CC and unique device identifier 813845020337. The recalled kits have lot numbers 1129763, 1137730, 1141819, and 1144572.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2605-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2605-2020 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.
