Reported Nov 21, 2018 · Terminated
INFUSE Bone Graft X SMALL KIT REF 7510100
Medtronic Sofamor Danek USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Sofamor Danek USA Inc · 1800 Pyramid Pl · Memphis, TN · 38132-1703
Is this the product you have?
- INFUSE Bone Graft X SMALL KIT REF 7510100
- Lot codes and dates
UDI 00613994239525Lot Number M111806AAA
- Amount recalled
- 138 units
Why it was recalled
The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
This product could cause temporary or reversible health problems — stop using it.
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