Skeletal Kinetics recalls ACUMED CALLOS INJECT 5CC bone void filler kits that may not maintain setting characteristics, potentially increasing surgery time or 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 ACUMED CALLOS INJECT 5CC bone void filler kits that may not set properly over time. This could lead to longer surgery, incomplete bone healing, or nonunion of bones after surgery.
The bone filler may not maintain its setting properties for the labeled shelf life. This could cause longer surgery times, incomplete bone healing, or nonunion of bones after the procedure.
Patients who have received ACUMED CALLOS INJECT 5CC for bone voids during surgery are most at risk. Medical professionals using this product for bone grafts may also be affected.
Check for product number 65-0005-S and unique device identifier 813845020238. The product was sold with lot numbers including 17091301, 17080401, and others listed in the recall notice.
Identify if your product has the product number 65-0005-S and unique device identifier 813845020238.
The product number is 65-0005-S.
Lot numbers 17091301, 17080401, 17092101, 17101914, 17110326, 1127621, 1129605, 1132312, 1132624, 1135465, and 1135954 are affected.
The bone filler may not maintain its setting characteristics for the labeled shelf life, which could increase surgery time or cause incomplete bone healing.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2594-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2594-2020 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.
