Skeletal Kinetics recalls SKAFFOLD FLOW (MX) 5CC 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 FLOW (MX) 5CC bone void filler kits because they may not stay set for the labeled time. This could lead to longer surgery, more anesthesia, or improper bone healing.
The bone void filler kits may not maintain their setting properties over time. This can cause longer surgical procedures, increased anesthesia needs, or incomplete bone healing, potentially leading to nonunion or delayed bone repair.
Patients who received the recalled SKAFFOLD FLOW (MX) 5CC kits for bone void filling during surgery are affected. Surgeons and medical staff using these kits for bone repair are most at risk.
Check for product number SKMX-FL05 and unique device identifier 813845020894. The recalled kits were sold with lot numbers 1136227 and 1137065.
Verify the product number SKMX-FL05 and unique device identifier 813845020894.
The SKAFFOLD FLOW (MX) 5CC bone void filler kits may not maintain their setting characteristics for the labeled shelf-life, which could increase surgery time or cause poor bone healing.
The recall record does not specify a remedy, so contact Skeletal Kinetics directly for guidance.
Lot numbers 1136227 and 1137065 are affected.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2628-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2628-2020 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.
