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-CMF10CC and UDI 813845020955.
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 surgery, incomplete bone healing, or complications like nonunion.
The bone void filler may not maintain its setting properties over time, which can cause longer surgical procedures. This could lead to incomplete bone healing or complications like delayed union or nonunion of the bone.
Patients who received the CRANIOSCULPT bone void filler kit with product number C-CMF10CC and UDI 813845020955 are affected. Surgeons and patients using this product for bone repair are most at risk.
Check for product number C-CMF10CC and unique device identifier (UDI) 813845020955 on the kit. The product is used for filling bone gaps in extremities, spine, or pelvis after surgery.
Look for product number C-CMF10CC and UDI 813845020955 on the kit.
The bone void filler may not maintain its setting characteristics for the labeled shelf-life, which could increase surgery time or cause incomplete bone healing.
Risks include longer surgical procedures, incomplete bone formation, delayed union, or nonunion of the bone.
Check for product number C-CMF10CC and UDI 813845020955 on the kit.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2635-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2635-2020 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.
