Medtronic Sofamor Danek INFUSE Bone Graft Kit Recall: Extra Collagen Sponges Risk
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.
Lower-risk recall
The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/69758-medtronic-sofamor-danek-infuse-bone-graft-kit-recall-extra-collagen.
Source Summary by GovInfoNow · govinfonow.com/recall/69758-medtronic-sofamor-danek-infuse-bone-graft-kit-recall-extra-collagen · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0440-2019
Cite this page
“Medtronic Sofamor Danek INFUSE Bone Graft Kit Recall: Extra Collagen Sponges Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69758-medtronic-sofamor-danek-infuse-bone-graft-kit-recall-extra-collagen. Based on FDA recall #Z-0440-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0440-2019%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check the product label for the lot number M111806AAA. The kit is identified by the reference number 7510100 and unique device identifier 00613994239525.
- Brand
Medtronic Sofamor Danek- Category
Medical device
What to do — step by step
Check Kit Label
Look for the lot number M111806AAA on the product label to confirm if it is affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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.
- Official source: FDA Recall #Z-0440-2019 (September 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0440-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.