| | Class 2 Device Recall AURORA Surgiscope System |  |
| Date Initiated by Firm | June 07, 2024 |
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| Date Posted | July 11, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2331-2024 |
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| Recall Event ID |
94804 |
| 510(K)Number | K232618 |
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| Product Classification |
Endoscope, neurological - Product Code GWG
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| Product | AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager. |
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| Code Information |
Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.
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Recalling Firm/
Manufacturer |
Integra LifeSciences Corp.
1100 Campus Rd
Princeton NJ 08540-6650
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| For Additional Information Contact | Lacey Gigante
1-609-2129004 |
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Manufacturer Reason
for Recall | Potential sheath damage that could lead to tissue damage and/or track hemorrhage. |
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FDA Determined
Cause 2 | Process change control |
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| Action | A "1st NOTIFICATION - URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter, dated 6/7/24, was mailed to consignees. The notification instructs consignees to immediately remove any affected devices from service and place them in quarantine. The recall notification is to be forwarded to users of the product within your facility for their awareness. Consignees are to complete the provided response form and return it via email to FCA3@integralife.com or by fax to 1-609-750-4220. Integra Customer Service will reach out to consignees regarding a Return Materials Authorization and return directions upon receipt of the response form. Consignees with any questions are to contact Customer Service from 8:00 AM to 8:00 PM from Monday to Friday by phone at 1-800-654-2873 or by email at custsvcnj@integralife.com |
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| Quantity in Commerce | 14 units |
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| Distribution | Domestic: NY, OH, & DC. |
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| 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 = GWG
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