Skeletal Kinetics recalls EXACTECH OSSILIX FIL (MX) 10CC bone filler kits that may not maintain setting characteristics, potentially increasing surgery time and causing incomplete 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 FIL (MX) 10CC bone filler kits because they may not stay set for the labeled time. This could lead to longer surgeries, incomplete bone healing, or nonunion of bones.
The bone filler may not maintain its setting characteristics for the labeled shelf-life. This could cause longer surgical times, incomplete bone formation, or nonunion of bones after healing.
Patients who received the recalled EXACTECH OSSILIX FIL (MX) 10CC bone filler kits during surgery. Those with bone voids or gaps in extremities, spine, pelvis, or trauma-related bone defects are most at risk.
Check for product number 660-02-10 and unique device identifier (UDI) 813845021013. The recalled kits were sold with lot numbers 17061403, 17092808, 1132568, 1135952, 1139367, 1140037, and 1144461.
Verify the product number (660-02-10) and UDI (813845021013) on the kit to confirm if it's recalled.
EXACTECH OSSILIX FIL (MX) 10CC bone filler kits with product number 660-02-10 and UDI 813845021013.
The product may not maintain its setting characteristics, potentially increasing surgery time and causing incomplete bone healing or nonunion.
Lot numbers 17061403, 17092808, 1132568, 1135952, 1139367, 1140037, and 1144461.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2606-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2606-2020 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.
