Medtronic Sofamor Danek recalls INFUSE Bone Graft X SMALL KIT REF 7510100 with lot M111806AAA due to potential extra collagen sponges. Affected patients should contact for guidance.
The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
Medtronic Sofamor Danek is recalling a specific bone graft kit that may contain two absorbable collagen sponges instead of one. This could lead to complications during surgery if the extra sponge is used.
The kit may contain two absorbable collagen sponges (ACS) instead of the required one. Using an extra sponge could cause complications during surgery, such as improper graft placement or increased bleeding.
Patients who received the INFUSE Bone Graft X SMALL KIT REF 7510100 with lot number M111806AAA are affected. Surgeons and medical staff using this kit during procedures are at higher risk.
Check the product label for the lot number M111806AAA. The kit is identified by the reference number 7510100 and unique device identifier 00613994239525.
Look for the lot number M111806AAA on the product label to confirm if it is affected.
The recall is for a potential extra collagen sponge, which could cause complications during surgery but is not immediately life-threatening.
Check the product label for lot number M111806AAA and reference number 7510100.
The recall does not specify a remedy, so contact Medtronic Sofamor Danek directly for guidance.
We’ve drafted a message you can send Medtronic Sofamor Danek to request your refund or repair — edit it as you like.
Subject: Recall Z-0440-2019 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-0440-2019 from Medtronic Sofamor Danek. 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.
