Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
This recall is currently active, issued October 25, 2023. It was issued by Medtronic Sofamor Danek Usa Inc.
- Company
- Medtronic Sofamor Danek Usa Inc
- Recall Initiated
- September 26, 2023
- Posted
- October 25, 2023
- Recall Number
- Z-0167-2024
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
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
Lot / Code Info
a) T43102: b) T43102INT: c) T43103INT: d) T43105: e) T43105INT: f) T43110: g) T43110INT:
Root Cause
Employee error
Action Taken
Medtronic issued an URGENT: MEDICAL PRODUCT RECALL notice to its consignees on 09/26/2023 via UPS 2-day delivery. The notice explained the problem, potential risk, and requested the return of the affected devices.