Surgical Patties and Strips Recalled for Elevated Endotoxin Levels
Codman Surgical Patties and Strips are being recalled due to higher-than-expected endotoxin levels in raw materials. Approximately 93,782 units were distributed worldwide for use in protecting tissue during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product used in sensitive surgical applications protecting central nervous system tissue. While endotoxin contamination is a recognized hazard in surgical devices, no illnesses or injuries have been reported. The FDA Class II classification without reported hospitalizations places this at Score 3 per the rubric.
Plain-English summary
Integra LifeSciences Corp. is recalling Codman Surgical Patties and Strips (Model 801408) due to higher-than-expected levels of endotoxin detected in raw materials used to produce the devices. The elevated endotoxin may have resulted in out-of-specification endotoxin levels in finished goods.
The affected surgical patties and strips are used to protect tissue, including brain and central nervous system tissue, during surgical procedures. The recall affects approximately 93,782 units distributed worldwide across numerous countries including the United States, Canada, Europe, Asia, and other regions.
No illnesses or injuries have been reported in association with this product. This is a Class II recall from the U.S. Food and Drug Administration.
The recalled product
- Product
- SURG PAT XRAY 1X3 Model/Catalog Number: 801408. 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.
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- endotoxin
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 10381780515036
- 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.
Distribution
Distributed nationwide across the United States.
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