Skeletal Kinetics recalls OSTEOVATION 10CC 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 10CC 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 set structure over time, causing it to fail during healing. This could require longer surgery, increase anesthesia time, or lead to incomplete bone formation, delayed healing, or nonunion.
Patients who received OSTEOVATION 10CC kits with specific lot numbers for bone void filling procedures are affected. Surgeons using these kits for bone repair are most at risk.
Check the product label for lot numbers: 1127160, 1127031, 1130303, 1138055, 1139832, or 1142076. The product is used for filling bone gaps in surgeries.
Look for lot numbers on the product label: 1127160, 1127031, 1130303, 1138055, 1139832, or 1142076.
The OSTEOVATION 10CC bone filler may not maintain its setting characteristics for the labeled shelf-life, which could lead to longer surgery times or poor bone healing.
Check the product label for the lot numbers listed. If you have one of the affected lots, contact Skeletal Kinetics for guidance.
The recall notes potential for longer surgery times and poor bone healing, but does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2617-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2617-2020 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.
