FDA-Device2023-11-01Class II
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Medtronic Sofamor Danek USA Inc
Hazard
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.
Sold states
US, Colombia, S. Korea, New Zealand, India, Taiwan
Affected count
430 units
Manufactured in
1800 Pyramid Pl, N/A, Memphis, TN, United States
Products
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0165-2024Don't want to check this manually?
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