Skeletal Kinetics recalls EXACTECH OSSILIX MP FIL 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 recalls EXACTECH OSSILIX MP FIL 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 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 fusion.
Patients who received the EXACTECH OSSILIX MP FIL 10CC bone void filler kit during surgery are affected. Surgeons and medical staff using the product are most at risk.
Check for product number 662-02-10 and unique device identifier 813845021051. The product was sold with lot numbers 17081106 and 17120617.
Verify the product number 662-02-10 and unique device identifier 813845021051 on the kit.
The product may not maintain its setting characteristics for the labeled shelf life, which could lead to longer surgery or improper bone healing.
The recall record does not specify a remedy, so contact Skeletal Kinetics directly for guidance.
Look for product number 662-02-10 and unique device identifier 813845021051, with lot numbers 17081106 or 17120617.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2636-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2636-2020 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.
