medical Class II Updated 2023-11-01

Medtronic Sofamor Danek USA Inc recalls Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c

Recalled Product

Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix


Hazard / Issue

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.

Issued by

FDA

Distribution: US, Colombia, S. Korea, New Zealand, India, Taiwan
Lot/Code Info: a) T43102: b) T43102INT: c) T43103INT: d) T43105: e) T43105INT: f) T43110: g) T43110INT:
View official government recall

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