Skeletal Kinetics recalls OSTEOVATION 3CC Impact Formula (product #390-2103) due to potential failure to maintain setting characteristics, risking longer surgery times or 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 3CC Impact Formula bone filler kits because they may not stay set for the labeled time. This could lead to longer surgeries, incomplete bone healing, or complications like nonunion.
The bone filler may not maintain its setting properties over time, which can cause it to fail during the healing process. This might require longer surgical time, increase anesthesia risks, or lead to incomplete bone formation and delayed healing.
Patients who received the recalled OSTEOVATION 3CC Impact Formula bone filler kits during surgery are affected. Those with bone voids filled with this product are at risk for longer healing times or complications.
Check for product number 390-2103 or unique device identifier (UDI) 813845020078 on the packaging. The product was sold with lot numbers 17051908, 17060107, 1132179, 1133245, 1135308, or 1142208.
Look for product number 390-2103 or UDI 813845020078 on the packaging to confirm if it's recalled.
The recall states the product may not maintain its setting characteristics, which could lead to longer surgery times or incomplete healing. It is not recommended for use as recalled.
The recall does not specify a remedy, so contact Skeletal Kinetics directly for guidance.
Check for product number 390-2103 or UDI 813845020078 on the packaging. The product was sold with specific lot numbers: 17051908, 17060107, 1132179, 1133245, 1135308, or 1142208.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2618-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2618-2020 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.
