Open, Classified

Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

FDA Recall Z-2207-2023 · Posted 2023-07-20

Recall StatusOpen, Classified

Product CodeGXQ

Date Initiated2023-06-13

Product Quantity65029

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.

Firm Action

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 [email protected] 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

Distribution Pattern

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, SC, OH, MA, DC, NM, WV, NH, CT, NV, OK, AR, KS, MT, RI, CO, ND, WY, VT and the countries of Barbados, Cayman Islands, Honduras, Belgium, Switzerland, Italy, United Kingdom, Canary Islands, Hungary, Poland, Germany, Spain, Czech Republic, Thailand, South Africa, Greece, Finland, Portugal, Colombia, Norway, Iraq, Jordan, Estonia, Austria, Slovakia, Libya, Qatar, Bosnia And Herzegovina, Algeria, Dominican Republic, Canada, Australia, New Zealand, Sweden, El Salvador, Ireland, United Arab Emirates, Saudi Arabia, Kazakhstan, Turkey, Mauritius, Ghana, Russian Federation, Lebanon, Romania, Iran, Islamic Republic Of, Egypt, Namibia, Senegal, Ecuador, Panama, Peru, Guyana, Mexico, Chile, Costa Rica, Viet Nam, Kuwait, Ukraine, Israel, Turkmenistan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2016-11-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.