Z-0440-2019 Class II Terminated
FDA device recall Z-0440-2019 was initiated by Medtronic Sofamor Danek USA Inc on Sep 27, 2018 and is designated Class II. Reason for recall: The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS. The recall status is terminated (terminated Sep 16, 2020). Affected quantity: 138 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 21, 2018
- Initiation Date
- Sep 27, 2018
- Termination Date
- Sep 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 138 units
Product Description
INFUSE Bone Graft X SMALL KIT REF 7510100
Reason for Recall
The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
Distribution Pattern
US
Code Information
UDI 00613994239525, Lot Number M111806AAA
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0440-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026