Skeletal Kinetics recalls EXACTECH OSSILIX FORM (MX) 5CC bone filler kits that may not maintain setting characteristics, risking longer surgery times 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 FORM (MX) 5CC bone filler kits because they may not stay set for the labeled time. This could lead to longer surgeries or improper bone healing.
The bone filler kits may not maintain their setting properties over time. This can cause longer surgical procedures, increased anesthesia time, or incomplete bone healing.
Patients who received the EXACTECH OSSILIX FORM (MX) 5CC bone filler kit during surgery are affected. Surgeons and medical staff using the product are at highest risk.
Check for product number 660-01-05 and unique device identifier 813845021020. The product was sold with lot number 1132473.
Verify the product number 660-01-05 and unique device identifier 813845021020.
The bone filler kits may not maintain their setting characteristics for the labeled shelf-life, which could lead to longer surgery times or improper bone healing.
The recall record does not specify a remedy, so contact Skeletal Kinetics directly for guidance.
The product is safe for use as intended, but the recall indicates a potential risk of longer surgery times or poor bone healing if the filler does not set properly.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2609-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2609-2020 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.
