Skeletal Kinetics recalls SKAFFOLD CMF IMPRESS (MP) 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 CMF IMPRESS (MP) 10CC 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 could cause longer surgical procedures, increased anesthesia needs, or incomplete bone healing, potentially leading to nonunion or delayed bone repair.
Patients who have received the SKAFFOLD CMF IMPRESS (MP) 10CC bone void filler kit during surgery are likely affected. Surgeons and medical staff who used the product are at higher risk.
Check for the product name 'SKAFFOLD CMF IMPRESS (MP) 10CC', product number CMMP-IM10, and unique device identifier 813845020696. The product was used to fill bone gaps in surgeries for extremities, spine, or pelvis.
Look for the product name 'SKAFFOLD CMF IMPRESS (MP) 10CC', product number CMMP-IM10, and unique device identifier 813845020696.
The product may not maintain its setting characteristics, which could lead to longer surgery or poor bone healing. It is not safe for the labeled shelf-life duration.
The recall does not specify a remedy, so contact Skeletal Kinetics directly for guidance.
Patients who received the product during surgery and medical staff who used it are most at risk.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2625-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2625-2020 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.
