Skeletal Kinetics recalls ACUMED IMPACT 10CC bone void filler kits that may not maintain setting characteristics, risking longer surgery or poor bone healing. Affected lots: 1126151, 1128829, 1129911, 1132480.
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 IMPACT 10CC bone void filler kits that may not stay set for the labeled time. This could lead to longer surgery, more anesthesia, or poor bone healing. Affected kits have specific lot numbers.
The bone filler may not hold its shape for the intended time after application. This can cause longer surgery, more anesthesia, or incomplete bone healing, which might lead to delayed or failed bone repair.
Patients who received ACUMED IMPACT 10CC bone void filler kits with the listed lot numbers during surgery. Surgeons and medical staff using these kits for bone repair are most at risk.
Check the lot numbers on the kit: 1126151, 1128829, 1129911, or 1132480. The product is used for filling bone gaps in surgeries for extremities, spine, or pelvis.
Look for the lot numbers 1126151, 1128829, 1129911, or 1132480 on the ACUMED IMPACT 10CC kit.
The bone filler may not maintain its setting characteristics for the labeled shelf-life, which could increase surgery time or cause poor bone healing.
Affected kits have lot numbers: 1126151, 1128829, 1129911, 1132480.
No, but you should check the lot number to see if your kit is affected. If it is, contact your surgeon for guidance.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2595-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2595-2020 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.
