Skeletal Kinetics recalls CRANIOSCULPT bone void filler kits that may not maintain setting characteristics, increasing surgery time or causing 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 bone void filler kits that might not stay set for the labeled time. This could lead to longer surgery, incomplete bone healing, or other complications.
The bone filler may not hold its shape over time, which can cause the surgery to take longer. This might lead to incomplete bone healing or other complications like delayed union or nonunion.
Patients who received CRANIOSCULPT bone void filler kits for skeletal repairs are affected. Those with recent bone surgery or trauma are at higher risk.
Check for product number C-CMF5CC and unique device identifier 813845020948. The product was sold with lot number 17040541.
Verify the product number (C-CMF5CC) and unique device identifier (813845020948) to confirm if your kit is affected.
The product may not maintain its setting characteristics, which could increase surgery time or cause incomplete bone healing.
The official recall notice does not specify a remedy or action steps beyond checking product details.
The recall states possible longer-term health consequences like incomplete bone formation or delayed healing, but does not specify injury risk.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2634-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2634-2020 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.
