FDA Recall
Open, Classified
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Recall: Z-0166-2024
·
Initiated September 26, 2023
Recall
- Recall Number
- Z-0166-2024
- Event Number
- 93163
- Firm
- Medtronic Sofamor Danek USA Inc
- FEI Number
- 1000477302
- Product Code
- MBP
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- September 26, 2023
- Posted
- October 25, 2023
- Address
- 1800 Pyramid Pl, Memphis, TN, 38132-1703
Description
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
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.
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.
Distribution
US, Colombia, S. Korea, New Zealand, India, Taiwan
Quantity
583 units