Skeletal Kinetics recalls EXACTECH OSSILIX FIL (MX) 5CC bone void fillers that may not maintain setting characteristics, risking longer surgery or poor bone healing. Product numbers and lot numbers provided.
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 EXACTECH OSSILIX FIL (MX) 5CC bone void fillers because they may not stay set for the labeled time. This could lead to longer surgeries, more anesthesia, or improper bone healing.
The bone void filler may not maintain its setting characteristics for the labeled shelf-life. This could cause longer surgical times, increased anesthesia needs, or incomplete bone healing.
Patients who received the EXACTECH OSSILIX FIL (MX) 5CC bone void filler during surgery are affected. Surgeons and medical staff who used this product are at highest risk.
Check for product number 660-02-05 and lot numbers: 17081103, 17092102, 17101915, 1127908, 1132493, 1135468, 1135945, 1139362, 1144457.
Look for product number 660-02-05 and lot numbers listed in the recall notice.
The recall states the product may not maintain setting characteristics, which could lead to longer surgery or poor bone healing. It is not recommended for use.
The recall does not specify a remedy, so check with your healthcare provider or the manufacturer for guidance.
Check for product number 660-02-05 and lot numbers: 17081103, 17092102, 17101915, 1127908, 1132493, 1135468, 1135945, 1139362, 1144457.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2607-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2607-2020 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.
