Recall Z-0244-2025 ยท HBA Neurosurgical Paddie
Integra LifeSciences Corp.
SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
| Date | Oct 29, 2024 (initiated Sep 20, 2024) |
| Status | Open, Classified |
| Reason | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods |
| Root cause | Nonconforming Material/Component |
| Action | Integra issued 1st Notification- Urgent: Voluntary Medical Device Recall letter via E-mail and FedEx overnight mail on 9/20/24. Letter states reason for recall, health risk and action to take: 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 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 rec |
| Quantity | 56082 |
| Distribution | Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand Netherlands (the) Belgium France Ireland Switzerland Brunei Darussalam Bahamas (the) South Africa China Ecuador Korea (th |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193346 | Codman Surgical Patties & Strips Integra LifeSciences Corporation, Nov 20, 2020 |