CODMAN® Surgical Strips and Patties X-Ray Detectable
Last updated
Summary
Product
CODMAN® Surgical Strips and Patties X-Ray Detectable
Issue
Medical devices - Sterility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| CODMAN® Surgical Strips X-Ray Detectable | More than 10 numbers, contact manufacturer. | 80-1456 80-1455 80-1449 80-1450 80-1451 80-1452 80-1454 80-1457 80-1453 |
| CODMAN® Surgical Patties X-Ray Detectable | More than 10 numbers, contact manufacturer. | 80-1398 80-1399 80-1401 80-1407 80-1408 80-1397 80-1400 80-1404 80-1406 80-1396 80-1402 80-1403 80-1409 |
Issue
During an internal investigation, Integra Lifesciences identified higher than expected levels of endotoxin within the raw material used to product CODMAN® Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods. Consequently, while the endotoxin levels identified were higher than expected, the possibility of adverse health consequences actually occurring remains remote.
Recall start date: October 7, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Integra Lifesciences Production Corporation
11 Cabot Blvd., Mansfield, Massachusetts, United States, 02048
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76389
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