FDA recall Z-0163-2024

Medtronic Sofamor Danek USA Inc · Class II · device

Product

Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; 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.

Distribution

US, Colombia, S. Korea, New Zealand, India, Taiwan

Key facts

Status
Ongoing
Initiation date
2023-09-26
Report date
2023-11-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0163-2024