Recall Z-0166-2024— Medtronic Sofamor Danek USA Inc

Name: FDA recall Z-0166-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-26

Class II · Ongoing

Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2023-09-26. It names 2 FDA 510(k) clearances: K051195, K043048. Product: Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix. 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..

Recalling firm: Medtronic Sofamor Danek USA Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-09-26
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

2 on FDA's record

K051195 — GRAFTON DBMOsteotech, Inc.·cleared 2005-12-16
K043048 — GRAFTON PLUS DBM PASTEOsteotech, Inc.·cleared 2005-11-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.