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Recall Observatory FDA recall evidence

Device product

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

Z-0167-2024

September 26, 2023

Class II

Product summary

Firm
Medtronic Sofamor Danek USA Inc
Event
Event 93163
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0167-2024

Official wording

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.

Code information: a) T43102: b) T43102INT: c) T43103INT: d) T43105: e) T43105INT: f) T43110: g) T43110INT:

Distribution pattern: US, Colombia, S. Korea, New Zealand, India, Taiwan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.