Skeletal Kinetics recalls CRANIOSCULPT C 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 C 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 kits may not maintain their setting properties over time, which could cause longer surgical procedures. This might lead to incomplete bone healing, delayed union, or nonunion of the bone.
Patients who received CRANIOSCULPT C 10CC bone filler kits for bony voids or gaps during surgery are affected. Those with recent bone surgery using this product are most at risk.
Check for product number C-C10CC and unique device identifier 813845021129. The kits were sold with lot numbers 17110307, 1126715, 1129289, 1137080, 1139373, 1139829, 1141989, or 1143094.
Verify the product number (C-C10CC) and unique device identifier (813845021129) to confirm if your kit is recalled.
Reach out to Skeletal Kinetics directly for guidance on next steps if you have the recalled product.
The bone filler kits may not maintain their setting characteristics for the labeled shelf-life, which could increase surgery time or cause incomplete bone healing.
Using the recalled kits might lead to longer surgical procedures, incomplete bone formation, delayed bone union, or nonunion of the bone.
Check for product number C-C10CC and unique device identifier 813845021129 with lot numbers 17110307, 1126715, 1129289, 1137080, 1139373, 1139829, 1141989, or 1143094.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2597-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2597-2020 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.
