Codman Surgical Patties and Strips recalled for elevated endotoxin levels
Integra LifeSciences has recalled Codman Surgical Patties and Strips (Model 801407) due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification endotoxin in finished products used in brain surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall involves surgical devices used in high-risk procedures (brain and central nervous system surgery) with documented quality control failures (out-of-specification endotoxin levels). Although no illnesses or injuries have been reported, the potential for serious harm to patients undergoing neurosurgery justifies a High severity classification.
Plain-English summary
Codman Surgical Patties and Strips (Model 801407) are being recalled by Integra LifeSciences Corp. These surgical devices are used to protect tissue, including brain and other tissues of the central nervous system, during surgical procedures.
The recall was initiated due to the detection of higher-than-expected endotoxin levels in raw materials used to manufacture the products. This resulted in finished goods that contained out-of-specification levels of endotoxin.
Approximately 201,914 units have been distributed worldwide, including throughout the United States, Canada, Europe, Asia, Africa, the Middle East, and Latin America. All unexpired products are included in the recall.
The recalled product
- Product
- SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. 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
- Affected units
- 201,914
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:10381780515029
- 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.
Distribution
Part of a larger recall action
This product is one of 22 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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