Skeletal Kinetics recalls SKAFFOLD RENU FLOW 5CC bone filler kits that may not maintain setting characteristics, increasing surgery time and risk of 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 recalls SKAFFOLD RENU FLOW 5CC bone filler kits because they may not set properly over time. This could lead to longer surgery, incomplete bone healing, or nonunion of bones after surgery.
The bone filler may not maintain its setting properties for the labeled shelf life. This can cause longer surgical procedures, increased anesthesia time, or improper bone healing like delayed union or nonunion.
Patients who have received the SKAFFOLD RENU FLOW 5CC bone filler kit during surgery are affected. Those with bone voids in extremities, spine, pelvis, or trauma-related bone defects are most at risk.
Check for product number SKMA-FL05 and unique device identifier 813845020849. The product is used for filling bone voids in extremities, spine, pelvis, or trauma-related bone defects.
Verify the product number SKMA-FL05 and unique device identifier 813845020849 to confirm if you have the recalled item.
The product is indicated for use in bone voids but may not maintain setting characteristics, potentially increasing surgery time and risk of incomplete healing.
The recall record does not specify a remedy, so contact Skeletal Kinetics directly for guidance.
The hazard may lead to longer surgery, increased anesthesia time, or improper bone healing, but the recall 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-2631-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2631-2020 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.
