Skeletal Kinetics recalls OSTEOVATIONEX 5CC bone void filler kits that may not maintain setting characteristics, increasing surgery time and risking 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 OSTEOVATIONEX 5CC bone void filler kits that may not set properly over time. This could lead to longer surgery, incomplete bone healing, or nonunion of bones after surgery.
The bone filler may not maintain its setting characteristics for the labeled shelf life. This can cause longer surgical procedures, incomplete bone healing, or nonunion of bones after surgery.
Patients who received OSTEOVATIONEX 5CC kits for bone voids during surgery. Surgeons and medical staff using the product are at higher risk due to potential complications.
Check for product number 390-0005 and unique device identifier (UDI) 813845020023. The kits were sold with lot numbers 17071104, 17100404, 1126669, 1128523, 1129958, 1135746, or 1142073.
Identify the product number (390-0005) and UDI (813845020023) to confirm if your kit is recalled.
The product may not maintain its setting characteristics, which could increase surgery time or cause incomplete bone healing. Consult your surgeon for specific risks.
The recall does not specify a remedy, so contact Skeletal Kinetics directly for guidance.
Check for product number 390-0005 and UDI 813845020023 with lot numbers 17071104, 17100404, 1126669, 1128523, 1129958, 1135746, or 1142073.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2622-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2622-2020 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.
