Hip replacement acetabular shell recalled for excessive deburring
Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER50D acetabular shells for hip replacements due to excessive deburring resulting in smooth edges on the shell.
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 an FDA Class II recall for a manufacturing defect (excessive deburring) in a hip replacement component with no reported illnesses or injuries. The defect represents a risk of improper implant function, meeting the criteria for High severity.
Plain-English summary
The TRIDENTII PSL CLUSTER50D acetabular shell, used in primary and revision hip replacement surgery for patients at high risk of dislocation, is being recalled by Howmedica Osteonics Corp. The product was distributed nationwide and internationally to Netherlands, Canada, Singapore, Spain, Sweden, and the UK.
The recall was initiated because the acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell. This manufacturing condition deviates from the intended product specifications.
The affected lot numbers are 14593551, 15432653, and 15432651. Patients who have received this implant should contact their healthcare provider or orthopedic surgeon. Healthcare providers should immediately cease using inventory from these lot numbers and follow instructions from Howmedica Osteonics Corp. regarding any further actions needed.
The recalled product
- Product
- TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- manufacturing-defect
- edge-defect
Distribution
Distributed nationwide across the United States.
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