Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT,...
FDA Recall #Z-0167-2024 — Class II — September 26, 2023
Product Description
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
Reason for Recall
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.
Recalling Firm
Medtronic Sofamor Danek USA Inc — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
N/A
Distribution
US, Colombia, S. Korea, New Zealand, India, Taiwan
Code Information
a) T43102: b) T43102INT: c) T43103INT: d) T43105: e) T43105INT: f) T43110: g) T43110INT:
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated