Medtronic recalls large bone void filler that may not set within labeled shelf life, potentially causing longer surgery and incomplete bone healing.
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's large bone void filler may not set properly within its intended time frame, which could lead to longer surgery and incomplete bone healing. This affects patients receiving the product for bone repair.
The bone filler may not maintain its setting characteristics over time, causing it to take longer to harden after implantation. This could lead to extended surgery time, incomplete bone filling, or delayed healing.
Patients who received the Medtronic Bone Void Filler, Large for bone repair surgery are most at risk. The product is used in medical procedures to fill bone voids.
Check for product number C07B or GTIN 00813845020511 on the packaging. The product was sold with lot number 1127302.
Look for product number C07B or GTIN 00813845020511 on the packaging.
The product may not set properly within the labeled time frame, which could lead to longer surgery and incomplete bone healing.
The recall does not specify a remedy, so contact Medtronic directly for guidance.
Check for product number C07B or GTIN 00813845020511 on the packaging. The product was sold with lot number 1127302.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2391-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2391-2020 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.
