Integra Titan Reverse Shoulder System Cutting Templates Recalled for Manufacturing Error
Integra LifeSciences Corp. is recalling 12 units of Reverse Shoulder System cutting templates because the threaded handle was welded backwards, resulting in an incorrect cutting angle.
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: The recall involves a medical device with a manufacturing defect that results in an incorrect surgical angle. This is classified as a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Integra LifeSciences Corp. is recalling 12 units of Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The affected products are identified by Lot Numbers PM0278 and PM0277. These templates are accessories used to project the osteotomy angle on the humeral head during surgical procedures.
The recall was initiated because a single lot of left and a single lot of right templates were manufactured incorrectly. Specifically, the threaded handle on the templates was welded backwards, which causes the cutting angle to be the reverse of the intended specification.
The affected units were distributed nationwide, including in Texas, California, Ohio, Mississippi, Virginia, Illinois, Tennessee, Georgia, Florida, and Arizona. Healthcare providers and facilities that have received these specific lots should stop using the templates and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the hume
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 12
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 (1)
- Lot Numbers PM0278 and PM0277
Distribution
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