Skeletal Kinetics recalls SKAFFOLD CMF IMPRESS (MP) 5CC bone 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 CMF IMPRESS (MP) 5CC bone void filler kits because they may not set properly over time. This could lead to longer surgery, increased anesthesia time, or improper bone healing.
The bone filler kits may not maintain their setting characteristics for the labeled shelf life. This can cause longer surgical procedures, increased anesthesia time, or incomplete bone healing, potentially leading to nonunion or delayed bone repair.
Patients who received the SKAFFOLD CMF IMPRESS (MP) 5CC bone filler kit during surgery are affected. Surgeons and medical staff using the product are at higher risk.
Check for product number CMMP-IM05 and unique device identifier 813845020689. The product is used for filling bone voids in extremities, spine, or pelvis during surgery.
Verify the product number CMMP-IM05 and unique device identifier 813845020689 to confirm if you have the recalled item.
The SKAFFOLD CMF IMPRESS (MP) 5CC bone filler kits may not maintain their setting characteristics for the labeled shelf life, which could lead to longer surgery, increased anesthesia time, or improper bone healing.
The recall record does not specify a remedy, so contact Skeletal Kinetics directly for guidance.
The product is intended for surgical use but may not set properly over time, potentially causing longer surgery or poor bone healing.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2626-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2626-2020 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.
