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Class 2 Device Recall GRAFTON DBM (Gel, Flex, Putty, Matrix, Crunch) |
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Date Initiated by Firm |
September 26, 2023 |
Date Posted |
October 25, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0167-2024 |
Recall Event ID |
93163 |
510(K)Number |
K051195
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Product Classification |
Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
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Product |
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix |
Code Information |
a) T43102:
b) T43102INT:
c) T43103INT:
d) T43105:
e) T43105INT:
f) T43110:
g) T43110INT:
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Recalling Firm/ Manufacturer |
Medtronic Sofamor Danek USA Inc 1800 Pyramid Pl Memphis TN 38132-1703
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Manufacturer 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.
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FDA Determined Cause 2 |
Employee error |
Action |
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. |
Distribution |
US, Colombia, S. Korea, New Zealand, India, Taiwan |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = MBP and Original Applicant = OSTEOTECH, INC.
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