Medtronic recalls small bone void filler that may not set correctly, leading to longer surgery and potential bone healing issues. Affected units have specific product numbers and lot numbers.
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Medtronic is recalling a small bone void filler that might not set properly within the labeled time. This could cause longer surgery times and potentially incomplete bone healing after implantation.
The bone filler may not maintain its shape during the intended shelf life. If it doesn't set correctly, it could lead to longer surgery times and incomplete bone healing, which might cause delayed or failed bone fusion.
Patients who received the recalled Medtronic Bone Void Filler, Small for bone grafting procedures are affected. Surgeons using this product for spinal or joint surgeries are most at risk.
Check for product number C07A or lot number 1127301 on the packaging. This product was sold as an injectable bone filler for spinal or joint surgeries.
Look for product number C07A or lot number 1127301 on the packaging.
The product may not maintain its setting characteristics for the labeled shelf-life duration, which could lead to longer surgery times and incomplete bone healing.
If the device doesn't set properly, it could cause longer surgery times and potential issues with bone healing, including delayed or failed bone fusion.
Check for product number C07A or lot number 1127301 on the packaging. This product was sold as an injectable bone filler for spinal or joint surgeries.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2390-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2390-2020 from Medtronic. 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.
