Skeletal Kinetics recalls CRANIOSCULPT C 5CC bone 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 5CC 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 can cause longer surgical procedures and potential issues with bone healing. This might result in incomplete bone formation, delayed healing, or nonunion of the bone.
Patients who received CRANIOSCULPT C 5CC bone filler kits for bony voids during surgery are affected. Those with specific lot numbers are most at risk.
Check the product label for lot numbers: 17110313, 1126716, 1129286, 1137077, 1139370, 1139826, or 1141986. The product is used for filling bony voids in surgeries.
Look for lot numbers on the product label: 17110313, 1126716, 1129286, 1137077, 1139370, 1139826, or 1141986.
CRANIOSCULPT C 5CC is a bone void filler used in surgeries to fill gaps in bones like extremities, spine, or pelvis.
The bone filler kits may not maintain their setting characteristics for the labeled shelf-life, which could lead to longer surgeries or poor bone healing.
Lot numbers 17110313, 1126716, 1129286, 1137077, 1139370, 1139826, and 1141986 are affected.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2599-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2599-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
