Skeletal Kinetics recalls OSTEOVATION EX 3CC Impact Formula for potential failure to maintain setting characteristics, risking longer surgery times or poor bone healing. Affected units have specific lot numbers.
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 EX 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 nonunion of bones.
The bone filler may not maintain its setting properties over time, which can cause the product to fail during healing. This might require longer surgical procedures or result in bones not healing properly.
Patients who received the recalled bone filler kits during surgery are most at risk. Surgeons and medical facilities using the product are also affected.
Check the product label for lot numbers: 17051907, 17102713, 1126984, 1156491, or 1136327. The product is used for filling bone gaps in surgeries.
Look for lot numbers on the product label: 17051907, 17102713, 1126984, 1156491, or 1136327.
The recall indicates 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 in the recalled lots.
The recall does not specify a remedy, so check the product lot number and contact Skeletal Kinetics for further instructions.
The product may not stay set for the labeled time, which could cause incomplete bone formation, delayed union, or nonunion of bones.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2612-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2612-2020 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.
