FDA Enforcement
Class II
Ongoing
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
Recall: Z-0167-2024
·
Reported November 1, 2023
Enforcement
- Recall Number
- Z-0167-2024
- Event ID
- 93163
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Sofamor Danek USA Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 1, 2023
- Initiation Date
- September 26, 2023
- Classification Date
- October 24, 2023
- Address
- 1800 Pyramid Pl, N/A, Memphis, TN, 38132-1703, United States
Description
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; 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.
Code Info
a) T43102: b) T43102INT: c) T43103INT: d) T43105: e) T43105INT: f) T43110: g) T43110INT:
Distribution
US, Colombia, S. Korea, New Zealand, India, Taiwan
Quantity
N/A