Skeletal Kinetics recalls OSTEOVATION 5CC injectable bone filler due to potential failure to maintain setting characteristics, risking longer surgery times or poor 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 5CC injectable bone filler kits because they may not stay set for the labeled time. This could lead to longer surgery, more anesthesia, or improper bone healing.
The bone filler may not maintain its setting properties over time, causing it to fail during the healing process. This could lead to longer surgery times, increased anesthesia needs, or incomplete bone formation.
Patients who received OSTEOVATION 5CC bone filler kits for bony voids or gaps during surgery are likely affected. Surgeons and patients using the product for bone repair are at risk.
Check for product number 390-2005 and unique device identifier (UDI) 813845020054. The product was sold with lot numbers 17040525, 17071105, 1127972, 1129957, and 1135744.
Verify the product number (390-2005) and UDI (813845020054) to confirm if your kit is recalled.
The product may not maintain its setting characteristics, which could lead to longer surgery times or poor bone healing. It is not recommended for use without checking the recall.
The recall does not specify a remedy, so contact Skeletal Kinetics directly for guidance.
Look for product number 390-2005 and UDI 813845020054 with lot numbers 17040525, 17071105, 1127972, 1129957, or 1135744.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2620-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2620-2020 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.
