Skeletal Kinetics recalls OSTEOVATION RMX 5CC bone void filler kits that may not maintain setting characteristics, increasing surgery time and risk of incomplete bone healing.
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 5CC bone void filler kits because they may not set properly over time. This could lead to longer surgery, incomplete bone healing, or nonunion of bones. Affected kits have specific lot numbers listed in the recall notice.
The bone void filler kits may not maintain their setting characteristics for the labeled shelf life. This can cause longer surgical procedures, increased anesthesia time, or incomplete bone healing, potentially leading to nonunion where bones fail to connect properly.
Patients who received OSTEOVATION RMX 5CC bone void filler kits during surgery are likely affected. Surgeons and medical staff who used these kits for bone repair are at higher risk.
Check the product label for lot numbers: 1125793, 11296002, 1132492, 1132347, 1134448, 1137064, or 1142080. The product is used for filling bone gaps in extremities, spine, or pelvis during surgery.
Look for lot numbers on the product label: 1125793, 1129602, 1132492, 1132347, 1134448, 1137064, or 1142080.
OSTEOVATION RMX 5CC is used to fill bone voids or gaps in extremities, spine, or pelvis during surgery.
The bone void filler kits may not maintain their setting characteristics for the labeled shelf life, which could increase surgery time, cause incomplete bone healing, or lead to nonunion.
Check the product label for lot numbers listed in the recall. If you have the affected lot numbers, contact Skeletal Kinetics for further instructions.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2616-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2616-2020 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.
