Skeletal Kinetics recalls CRANIOSCULPT C 3CC bone void filler kits that may not maintain setting characteristics, risking longer surgery or poor bone healing. Affected units have specific lot numbers.
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 3CC bone void filler kits because they may not stay set for the labeled time. This could lead to longer surgeries, incomplete bone healing, or nonunion of bones.
The bone void filler kits may not maintain their setting properties over time, which can cause the product to fail during the healing process. This might require longer surgery, increase anesthesia time, or lead to incomplete bone formation, delayed healing, or nonunion.
Patients who received CRANIOSCULPT C 3CC kits with specific lot numbers for bone void filling procedures are affected. Those with the product in use are most at risk.
Check the product label for lot numbers: 17110310, 1129283, or 1140612. The product is used for filling bony voids in surgical procedures.
Look for lot numbers 17110310, 1129283, or 1140612 on the CRANIOSCULPT C 3CC kit.
CRANIOSCULPT C 3CC is a bone void filler used to fill gaps in the skeletal system during surgery.
The product may not maintain its setting characteristics for the labeled shelf-life, which could lead to longer surgery times or poor bone healing.
Check the lot number on the product. If it matches 17110310, 1129283, or 1140612, contact Skeletal Kinetics for guidance.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2598-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2598-2020 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.
