FDA-Device2023-11-01Class II
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; 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
N/A
Manufactured in
1800 Pyramid Pl, N/A, Memphis, TN, United States
Products
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0167-2024Don't want to check this manually?
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