Skeletal Kinetics recalls OSTEOVATION RMX 10CC bone filler kits that may not maintain setting characteristics, risking longer surgery times or poor bone healing. Product numbers 390-6002 and UDI 813845021099 affected.
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 OSTEOVATION RMX 10CC bone filler kits because they may not set properly over time. This could lead to longer surgeries, incomplete bone healing, or nonunion of bones. Patients using these kits should contact the manufacturer for guidance.
The bone filler may not maintain its setting properties after being applied, which can cause it to fail during the healing process. This might require longer surgery times, increase anesthesia risks, or lead to incomplete bone healing.
Patients who received OSTEOVATION RMX 10CC bone filler kits for bony voids during surgery are most at risk. The product is used in specific surgical procedures for bone gaps.
Check for product number 390-6002 or unique device identifier (UDI) 813845021099 on the kit. The product is used to fill bone gaps in surgeries for extremities, spine, or pelvis.
Reach out to Skeletal Kinetics for specific guidance on whether your kit is affected and next steps.
The product may not maintain its setting characteristics, which could lead to longer surgery times or poor bone healing. Consult Skeletal Kinetics for your specific case.
Contact Skeletal Kinetics directly to determine if your kit is affected and follow their instructions.
Check for product number 390-6002 or UDI 813845021099 on the kit. The product is used for filling bone gaps in surgeries for extremities, spine, or pelvis.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2615-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2615-2020 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.
