Skeletal Kinetics recalls SKAFFOLD RENU FLOW 10CC bone void filler kits that may not maintain setting characteristics, risking longer surgery 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 SKAFFOLD RENU 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.
The bone void filler kits may not maintain their setting characteristics for the labeled shelf life. This could cause longer surgical times, incomplete bone formation, or delayed bone healing after surgery.
Patients who received the SKAFFOLD RENU FLOW 10CC bone void filler kit during surgery are likely affected. Surgeons and medical staff who used this product are at higher risk.
Check for product number SKMA-FL10 and unique device identifier 813845020856. The product was used to fill bony voids in surgeries for extremities, spine, or pelvis.
Reach out to Skeletal Kinetics directly for guidance on next steps.
The product may not maintain its setting characteristics, which could lead to longer surgery or poor bone healing. Consult your surgeon for specific risks.
The recall does not specify a remedy, so contact Skeletal Kinetics directly for guidance.
Look for product number SKMA-FL10 and unique device identifier 813845020856. The product was used to fill bony voids in surgeries for extremities, spine, or pelvis.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2630-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2630-2020 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.
