Skeletal Kinetics recalls CRANIOSCULPT FLOW 10CC 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 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 intended shelf life. This can cause longer surgical times, incomplete bone healing, or complications like delayed union or nonunion of the bone.
Patients who received the CRANIOSCULPT FLOW 10CC bone filler kits during surgery are most at risk. The product is used for filling bone voids in extremities, spine, or pelvis after trauma or surgery.
Check for product number C-FLOW10CC and unique device identifier 813845020368. The kits were sold with lot numbers 17040528, 17100408, 1126463, 1127977, 1129766, 1137084, 1139620, or 1141816.
Verify the product number C-FLOW10CC and unique device identifier 813845020368 on the kit.
The bone filler may not maintain its setting characteristics for the labeled shelf life, which could lead to longer surgery times or incomplete bone healing.
Possible risks include longer surgical times, incomplete bone formation, delayed union, or nonunion of the bone.
Check for product number C-FLOW10CC and unique device identifier 813845020368. The kits were sold with specific lot numbers: 17040528, 17100408, 1126463, 1127977, 1129766, 1137084, 1139620, or 1141816.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2601-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2601-2020 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.
