Skeletal Kinetics recalls SKAFFOLD FLOW 3CC and SKAFFOLD FLOW (MX) 3CC bone fillers that may not maintain setting characteristics, increasing surgery time and risking 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 FLOW 3CC and SKAFFOLD FLOW (MX) 3CC bone fillers 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 kits may not maintain their setting properties over time. This can cause longer surgery times, incomplete bone formation, or delayed healing, potentially leading to nonunion where bones fail to connect properly.
Patients who received these bone fillers for skeletal voids during surgery are affected. Surgeons and medical staff using the product are at higher risk.
Check for product number SKMX-FL03 and unique device identifier 813845020887. These bone fillers are used for filling bony voids in extremities, spine, or pelvis during surgery.
Look for product number SKMX-FL03 and unique device identifier 813845020887 on the packaging or label.
The bone filler kits may not maintain their setting characteristics for the labeled shelf-life, which could increase surgery time and risk incomplete bone healing or nonunion.
Using the product may lead to longer surgery times, incomplete bone formation, delayed healing, or nonunion of bones.
Check for product number SKMX-FL03 and unique device identifier 813845020887 on the packaging or label.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2627-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2627-2020 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.
