Skeletal Kinetics recalls ACUMED CALLOS INJECT 3CC bone filler kits that may not maintain setting characteristics, risking longer surgery times or poor bone healing. Product numbers and lot numbers listed.
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 ACUMED CALLOS INJECT 3CC bone filler kits because they may not set properly over time. This could lead to longer surgery times, 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 ACUMED CALLOS INJECT 3CC for bone voids during surgery are most at risk. The product is used in specific surgical procedures for bone gaps.
Check for product number 65-0003-S and lot numbers: 17091305, 17091304, 17091303, 17101916, 17110325, 1126148, 1129604, 1135939.
Look for product number 65-0003-S and lot numbers listed in the recall notice.
ACUMED CALLOS INJECT 3CC bone filler kits used for filling bone voids during surgery.
The bone filler may not maintain its setting characteristics for the labeled shelf life, which could lead to longer surgery times or poor bone healing.
Check for product number 65-0003-S and lot numbers: 17091305, 17091304, 17091303, 17101916, 17110325, 1126148, 1129604, 1135939.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2593-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2593-2020 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.
