FDA Recall
Terminated
INFUSE Bone Graft X SMALL KIT REF 7510100
Recall: Z-0440-2019
·
Initiated September 27, 2018
Recall
- Recall Number
- Z-0440-2019
- Event Number
- 81171
- Firm
- Medtronic Sofamor Danek USA Inc
- FEI Number
- 1000477302
- Product Code
- NEK
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- September 27, 2018
- Terminated
- September 16, 2020
- Address
- 1800 Pyramid Pl, Memphis, TN, 38132-1703
Description
INFUSE Bone Graft X SMALL KIT REF 7510100
Reason
The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
Action
The firm initiated the recall by letter on 09/27/2018. The firm will coordinate the return of the recalled product.
Distribution
US
Quantity
138 units