AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
FDA device recall Z-2331-2024 · posted 2024-07-11 · Open, Classified
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
- Action taken
- 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
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- GWG
- Quantity affected
- 14 units
- Distribution
- Domestic: NY, OH, & DC.
- Date initiated
- 2024-06-07
- Date posted
- 2024-07-11
- Location
- Princeton, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Aurora Surgiscope System (K232618) | Rebound Therapeutics Corporation | 2023-10-27 |