Skeletal Kinetics recalls ACUMED CALLOS INJECT 10CC bone void filler kits that may not maintain setting characteristics, risking longer surgery times or 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 10CC bone void filler kits that may not set properly over time. This could lead to longer surgery times or improper bone healing after use.
The bone void filler may not maintain its setting characteristics for the labeled shelf-life. This could increase surgical time or cause incomplete bone formation, delayed healing, or nonunion.
Patients undergoing bone surgery who use the recalled ACUMED CALLOS INJECT 10CC kits are most at risk, particularly those with bone voids needing repair.
Check for product number 65-0010-S and unique device identifier (UDI) 813845020245. The kits were sold with lot numbers including 17092807, 17101601, 17102508, 17110324, 1126149, 1132567, 1135953, 1137074, and 1140039.
Verify the product number (65-0010-S) and UDI (813845020245) to confirm if your kit is recalled.
The product may not maintain its setting characteristics, which could increase surgical time or cause incomplete bone healing. Consult your surgeon for specific risks.
The recall record does not specify a remedy, so contact Skeletal Kinetics directly for guidance.
Check for product number 65-0010-S and UDI 813845020245 with lot numbers listed in the recall.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2592-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2592-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
