FDASeptember 27, 2018device
INFUSE Bone Graft X SMALL KIT REF 7510100
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
What to do
FDA enforcement status: Terminated
Brands named
medtronic sofamor danekmedtronicmedtronic sofamor
UPCs
00613994239525
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAOctopus 4 Tissue Stabilizer, Model 294002026-05-12
- FDAMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter2026-04-21
- FDAMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter2026-04-21
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