Skeletal Kinetics recalls OSTEOVATIONEX 3CC bone filler kits that may not maintain setting characteristics, risking longer surgery times or poor bone healing. Affected units have specific lot numbers.
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 OSTEOVATIONEX 3CC bone filler kits because they may not stay set for the labeled time. This could lead to longer surgeries, incomplete bone healing, or nonunion of bones.
The bone filler kits may not maintain their setting characteristics over time, which can cause longer surgical procedures. This may result in incomplete bone healing, delayed union, or nonunion of bones.
Patients who received OSTEOVATIONEX 3CC bone filler kits during surgery are affected. Surgeons and medical staff using the product are at risk if the kits fail to set properly.
Check the lot numbers: 17100402, 1127942, 1130302, 1135740, 1142070, 1142943. The product is used for filling bone voids in surgeries.
Look for lot numbers 17100402, 1127942, 1130302, 1135740, 1142070, or 1142943 on the packaging.
The bone filler kits may not maintain their setting characteristics for the labeled shelf-life, which could lead to longer surgery times or poor bone healing.
Check the lot numbers on the packaging. If it matches the listed numbers, contact Skeletal Kinetics for further instructions.
The recall indicates potential for longer surgeries and poor 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-2623-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2623-2020 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.
