Skeletal Kinetics recalls SKAFFOLD FLOW 10CC bone void filler kits that may not maintain setting characteristics, risking longer surgery or poor bone healing. Affected units have product number SKMX-FL10 and UDI 813845020900.
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 recalls SKAFFOLD FLOW 10CC bone void filler kits because they may not set properly over time. This could lead to longer surgery, incomplete bone healing, or nonunion of bones. Patients using these kits should stop using them and contact the manufacturer.
The bone void filler may not maintain its setting properties after being used, which can cause it to fail during the healing process. This might require longer surgery time or lead to incomplete bone formation, delayed healing, or nonunion of bones.
Patients who have received SKAFFOLD FLOW 10CC bone void filler kits for surgical bone repair are affected. Those with recent bone surgery using this product are most at risk.
Check for product number SKMX-FL10 and unique device identifier (UDI) 813845020900 on the packaging. The product is used for filling bone gaps in surgeries for extremities, spine, or pelvis.
Look for product number SKMX-FL10 and UDI 813845020900 on the packaging.
The product may not maintain its setting characteristics over time, which could lead to longer surgery or poor bone healing. It is not recommended for use as described.
The recall does not specify a remedy, so contact Skeletal Kinetics directly for guidance.
The recall indicates the product may not set properly, so it is not recommended for use. Check with the manufacturer for specific instructions.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2629-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2629-2020 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.
