FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: INFUSE Bone Graft X SMALL KIT REF 7510100
- Recall number
- Z-0440-2019
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- INFUSE Bone Graft X SMALL KIT REF 7510100
- Status
- Terminated
- Initiated
- 2018-09-27
- Posted
- not on file
- Terminated
- 2020-09-16
- Reason
- The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
- Root cause
- Error in labeling
- Action
- The firm initiated the recall by letter on 09/27/2018. The firm will coordinate the return of the recalled product.
- Quantity
- 138 units
- Distribution
- US
- Lot, serial or model codes
- UDI 00613994239525, Lot Number M111806AAA
- 510(k) numbers
- not on file
- PMA numbers
- ["P000058","P050053"]
- Product code
- NEK
- Firm FEI
- 1000477302
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28