Skeletal Kinetics recalls OSTEOVATIONEX 2CC injectable bone filler due to potential failure to 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 OSTEOVATIONEX 2CC injectable bone filler kits because they may not stay set for the labeled time. This could lead to longer surgeries, incomplete bone healing, or complications like nonunion.
The bone filler may not maintain its setting properties over time, causing it to fail during the healing process. This could lead to longer surgery times, incomplete bone formation, or complications like delayed healing or nonunion.
Patients who received OSTEOVATIONEX 2CC bone filler kits with lot numbers 1127941, 1130301, or 1135741 during surgery are affected. Surgeons and medical staff using these kits for bone voids are most at risk.
Check for lot numbers 1127941, 1130301, or 1135741 on the OSTEOVATIONEX 2CC injectable bone filler kits. These kits were sold for filling bone voids in extremities, spine, or pelvis.
Look for lot numbers 1127941, 1130301, or 1135741 on the product packaging.
The OSTEOVATIONEX 2CC bone filler may not maintain its setting characteristics for the labeled shelf-life, which could lead to longer surgery times or incomplete bone healing.
Check the lot number on the product. If it matches 1127941, 1130301, or 1135741, contact Skeletal Kinetics for guidance.
The recall indicates potential for longer surgery times or incomplete bone healing, but does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2621-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2621-2020 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.
