Z-0250-2025Class II
SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the...
Integra LifeSciences Corporation / initiated 2024-09-20 / Open, Classified / root cause: manufacturing process
Integra LifeSciences Corp. began a recall of SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0250-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Integra LifeSciences Corporation
- Product
- SURG STRP 1/2X6 Model/Catalog Number: 801451. 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.
- Product code
- HBA Neurosurgical Paddie
- Reason for recall
- 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 tag
- manufacturing process
- FDA 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 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 [email protected] 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 which you returned. PLEASE NOTE THAT REGARDLESS OF WHETHER YOU HAVE THE AFFECTED PRODUCT TO RETURN OR NOT A COMPLETED ACKNOWLEDGEMENT IS REQUIRED Additional actions to be Taken by Integra Sales Representatives and/or Distributors: 7. Check your customer traceability records for shipments of above catalog and lot numbers. 8. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number. 9. Distributors can request a credit for the quantities which they returned. Should you have any questions regarding these instructions, please contact your Integra Sales Representative or Customer Service from Monday to Friday 8:00 a.m. 8:00 p.m. EST at 1-800-654-2873 or [email protected].
- 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 (the Republic of) Czechia Kuwait Luxembourg French Guiana Mayotte Burundi Reunion Martinique Poland Costa Rica Japan Senegal Turkey Serbia Mexico Cambodia Spain Ghana Iceland Jersey Iraq Bahrain Lebanon Dominican Republic (the) Singapore Portugal Greece Austria C¿te d'Ivoire Palestine, State of Georgia Nigeria Slovenia Sweden Colombia United Arab Emirates (the) Saudi Arabia Qatar Hong Kong Oman Albania Panama Holy See (the) Kenya Pakistan Guernsey Morocco Chile Brazil Argentina Puerto Rico Rwanda Jordan Philippines (the) Hungary Romania Bolivia (Plurinational State of) Malaysia El Salvador Peru Lithuania Republic of North Macedonia Taiwan (Province of China) Israel Cyprus Bulgaria
- Product codes and lots
- UDI-DI: 10381780515074, 20886704036590 Note: the same product code was distributed for a few years under JnJ under a transition agreement with Integra. Therefore, 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0235-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0236-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0237-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0238-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0239-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0240-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0241-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0242-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0243-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0244-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0245-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0246-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0247-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0248-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0249-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0250-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0251-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0252-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0253-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0254-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0255-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0256-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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