FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
- Recall number
- Z-0161-2024
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
- Status
- Open, Classified
- Initiated
- 2023-09-26
- Posted
- 2023-10-25
- Terminated
- not on file
- Reason
- Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
- Root cause
- Employee error
- Action
- Medtronic issued an URGENT: MEDICAL PRODUCT RECALL notice to its consignees on 09/26/2023 via UPS 2-day delivery. The notice explained the problem, potential risk, and requested the return of the affected devices.
- Quantity
- 84 units
- Distribution
- US, Colombia, S. Korea, New Zealand, India, Taiwan
- Lot, serial or model codes
- GTIN 00643169123113, Serial Numbers: A59083-054, A59083-055, A59083-056, A59083-057, A59083-058, A59083-059, A59083-060, A59083-061, A59083-062, A59083-063, A59083-064, A56737-049, A56737-050, A56737-051, A56737-052, A56737-053, A56737-054, A56737-055, A56737-056, A56737-057, A56737-058, A56737-059, A56737-060, A56737-061, A56737-062, A56737-063, A56858-021, A56858-022, A56858-023, A56858-024, A56858-025, A56858-026, A56858-027, A56858-028, A56858-029, A56858-030, A56858-031, A56858-032, A56858-033, A56858-034, A56858-035, A56858-036, A57174-060, A57174-061, A57174-062, A57174-063, A57174-064, A57174-065, A57174-066, A57174-067, A57174-068, A57174-069, A57174-070, A57174-071, A57617-066, A57617-067, A57617-068, A57617-069, A57617-070, A57617-071, A57617-072, A57617-073, A57617-074, A57617-075, A57617-076, A57617-077, A57617-078, A58281-035, A58281-036, A58281-037, A58281-038, A58281-039, A58281-040, A58281-041, A58281-042, A58281-043, A58281-044, A58281-045, A58281-046, A58281-047, A59083-050, A59083-051, A59083-052, A59083-053
- 510(k) numbers
- ["K051195"]
- PMA numbers
- not on file
- Product code
- MBP
- 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