Skeletal Kinetics recalls Cranio/Sculpt C 10cc bone void filler due to potential mix-up with unsterilized OsteoVation EX. Affected units have UDI 00813845021129. No action needed if product was used properly.
Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.
Skeletal Kinetics is recalling Cranio/Sculpt C 10cc bone void filler products that may have been contaminated with unsterilized OsteoVation EX. This mix-up could pose a risk if the product was not properly sterilized before use in neurosurgery.
The recall involves a potential mix-up where one unit of OsteoVation EX (3cc) that wasn't sterilized was mistakenly packaged as Cranio/Sculpt C (10cc). This could lead to unsterilized material being used in neurosurgery, increasing infection risk.
Medical professionals using Cranio/Sculpt C for neurosurgery may be affected. Patients who received the product without proper sterilization could face infection risks.
Check for the unique device identifier (UDI) 00813845021129 on the product label. Cranio/Sculpt C is a calcium phosphate bone void filler used in neurosurgery for cranial bone defects.
Look for the unique device identifier (UDI) 00813845021129 on the Cranio/Sculpt C product label.
No, the recall only applies to units that may have been contaminated with unsterilized OsteoVation EX. Properly sterilized products are safe.
Check the product label for UDI 00813845021129. If you have the UDI, contact Skeletal Kinetics for guidance.
The recall indicates a potential mix-up with unsterilized material, which could increase infection risk if used improperly.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2054-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2054-2020 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.
