Medtronic recalls bone void filler kits that may not set correctly, causing longer surgery times and potential bone healing issues. Affected kits have product number EL153B.
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 bone void filler kits that may not set properly within the labeled shelf life. This could lead to longer surgery times and potential complications like delayed bone healing or nonunion.
The bone filler may not maintain its shape after injection, leading to longer surgery times. If it moves from its intended position before setting, it could cause incomplete bone healing or delayed union.
Patients who received the recalled bone void filler kits for bone repair surgery are affected. Surgeons and medical staff using these kits during procedures are at risk.
Check for product number EL153B on the kit. The kit was sold in the US with GTIN 00643169157248 and lot number 0009541707.
Look for product number EL153B on the kit label.
The product number is EL153B.
The product may not maintain its setting characteristics for the labeled shelf-life duration, which could lead to longer surgery times and potential bone healing complications.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2389-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2389-2020 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.
