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.
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 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.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Howmedica Osteonics 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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