FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
- Recall number
- Z-0167-2024
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; 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
- not on file
- Distribution
- US, Colombia, S. Korea, New Zealand, India, Taiwan
- Lot, serial or model codes
- a) T43102: b) T43102INT: c) T43103INT: d) T43105: e) T43105INT: f) T43110: g) T43110INT:
- 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