Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAI

FDA device recall Z-2207-2023 · posted 2023-07-20 · Open, Classified

Recall details

Recalling firm

Medtronic Neurosurgery

Reason for recall

Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an acute inflammatory process, comparable to infection.

Action taken

On 6/13/23 recall notices were mailed to customers and distributors and they were asked to do the following: 1) Return affected product to the recalling firm. 2) Complete and return the Customer Confirmation Form to neuro.quality@medtronic.com 3) This notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. Customers with questions can contact Customer Service at 800-874-5797 Option 1.

Root cause

Process change control

Status

Open, Classified

Product code

GXQ

Quantity affected

65029

Distribution

Worldwide - US Nationwide distribution including in the states of PR, TX, WA, HI, MI, GA, AL, IL, IN, IA, MO, KY, NY, CA, AZ, PA, UT, ME, MD, MN, FL, AK, NE, VA, OR, WI, NC, LA, SD, TN, MS, DE, NJ, ID

Date initiated

2023-06-13

Date posted

2023-07-20

Location

Irvine, CA

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