Skeletal Kinetics recalls OSTEOVATION Impact 10CC bone filler kits that may not maintain setting characteristics, risking longer surgery times or poor bone healing. Affected products 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 OSTEOVATION Impact 10CC 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 may not maintain its setting properties over time, which could cause longer surgery times or poor bone healing. This might lead to incomplete bone formation, delayed union, or nonunion of bones.
Patients who received OSTEOVATION Impact 10CC bone filler kits during surgery are most at risk. The product is used for filling bone gaps in surgeries for extremities, spine, or pelvis.
Check for product lot numbers: 17051914, 17060506, 1127991, 1128827, 1132180, 1132479, 1134902, or 1142212. The product is sold as OSTEOVATION Impact 10CC or OSTEOVATION 10CC Impact Formula.
Look for lot numbers on the product packaging: 17051914, 17060506, 1127991, 1128827, 1132180, 1132479, 1134902, or 1142212.
OSTEOVATION Impact 10CC is a bone void filler used to fill gaps in bones during surgery for extremities, spine, or pelvis.
The bone filler may not maintain its setting characteristics for the labeled shelf-life, which could lead to longer surgery times or poor bone healing.
Check the product lot number to see if it's affected. If it matches the listed numbers, contact Skeletal Kinetics for further instructions.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2614-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2614-2020 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.
