Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Reported: November 1, 2023 Initiated: September 26, 2023 #Z-0166-2024
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.
Details
- Recalling Firm
- Medtronic Sofamor Danek USA Inc
- Units Affected
- 583 units
- Distribution
- US, Colombia, S. Korea, New Zealand, India, Taiwan
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 583 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2023. Severity: Moderate. Recall number: Z-0166-2024.
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