Skeletal Kinetics recalls MEDTRONIC Bone Void Filler Large (Product Number C07B) due to potential longer healing times or incomplete bone formation. 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 recalls MEDTRONIC Bone Void Filler Large products that may not maintain their setting characteristics over time. This could lead to longer surgery, incomplete bone healing, or nonunion of bones.
The bone void filler may not stay set for the labeled time, causing longer surgery or healing issues. This could result in incomplete bone formation, delayed healing, or nonunion of bones.
Patients who received the recalled bone void filler during surgery are affected. Those with specific lot numbers (17040508, 17091408, 1127302, 1129303, 1129715) are most at risk.
Check the product label for lot numbers: 17040508, 17091408, 1127302, 1129303, or 1129715. The product is used for filling bone gaps in surgeries.
Look for the lot numbers listed: 17040508, 17091408, 1127302, 1129303, or 1129715 on the product label.
MEDTRONIC Bone Void Filler, Large (Product Number C07B).
Lot numbers 17040508, 17091408, 1127302, 1129303, and 1129715.
The product may not maintain its setting characteristics for the labeled shelf-life, potentially leading to longer surgery times or incomplete bone healing.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2610-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2610-2020 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.