AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Produ

FDA device recall Z-1295-2025 · posted 2025-03-06 · Open, Classified

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

Possibility for the obturator to break (separate).

Action taken

On February 6, 2025, URGENT: VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Actions to be Taken by Customers: 1. If you do have units of the affected product listed in Table 1, remove them immediately from service and quarantine them. 2. If you do have affected product, check the box on the enclosed Acknowledgement Form I do have affected product. Record the lot number(s) and total quantity of the affected product that you have. 3. Forward this notice to those who utilize the product so they are aware of this recall and can identify and quarantine any affected product that may remain in clinical areas. 4. If you do not have affected product, check the box, I do not have affected product. 5. Complete the rest of the Acknowledgement Form and return to FCA@integralife.com or FAX to 1-609-750- 4220. 6. Keep a copy of the form for your records. 7. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. You can request a credit for the quantities returned. Please note credit is applicable only for unexpired product. Receipt of this form ensures that Integra has achieved a level of effectiveness in communicating this information. We recommend you also maintain a copy of this notification and the signed copy of the acknowledgement form for your records. Regulatory agencies such as the FDA perform audits of field actions of this nature to verify that our customers have been notified and understand the nature of the field action. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com In addition, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mai

Root cause

Process control

Status

Open, Classified

Product code

GWG

Quantity affected

623 units

Distribution

US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC.

Date initiated

2025-02-06

Date posted

2025-03-06

Location

Princeton, NJ

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