Skeletal Kinetics recalls CRANIOSCULPT bone void filler kits that may not maintain setting characteristics, risking longer surgery or poor bone healing. Affected units have product number C-CMF3CC and UDI 813845020931.
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 bone void filler kits that may not stay set for the labeled time. This could lead to longer surgeries, incomplete bone healing, or nonunion of bones. Patients using these kits should contact the manufacturer.
The bone void filler kits may not maintain their setting characteristics over time. This can cause longer surgical procedures, incomplete bone formation, or delayed healing, potentially leading to nonunion of bones.
Patients who have received CRANIOSCULPT bone void filler kits for skeletal repairs are affected. Those with recent bone surgery using this product are most at risk.
Check for product number C-CMF3CC and unique device identifier (UDI) 813845020931 on the packaging. The product is used for filling bony voids in skeletal repairs.
Reach out to Skeletal Kinetics to confirm if your product is affected and get instructions.
The product may not maintain its setting characteristics, which could lead to longer surgeries or poor bone healing. Consult the manufacturer for specific guidance.
Contact Skeletal Kinetics to determine if your product is affected and follow their instructions.
Check for product number C-CMF3CC and UDI 813845020931 on the packaging.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2633-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2633-2020 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.
