Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
Reported: November 1, 2023 Initiated: September 26, 2023 #Z-0167-2024
Product Description
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; 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
- N/A
- Distribution
- US, Colombia, S. Korea, New Zealand, India, Taiwan
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: N/A.
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-0167-2024.
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