Hip prosthesis shells recalled for manufacturing deburring defect
Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER52E hip prostheses with excessive deburring on the acetabular shell edge, which could affect implant stability. Three units were distributed nationwide and internationally.
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 a risk-of-harm product—a defective hip prosthesis—where injury has not yet been reported. While classified as FDA Class II, the defect affects a high-risk patient population (revision patients prone to dislocation), and the manufacturing issue could compromise implant stability.
Plain-English summary
Howmedica Osteonics Corp. is recalling the TRIDENTII PSL CLUSTER52E hip prosthesis system, indicated for use in primary and revision patients at high risk of hip dislocation. The recalled units have Lot Numbers 14876553 and 14876552.
The acetabular shell in the recalled units may have excessive deburring, resulting in a smooth surface on the shell edge. This manufacturing defect could potentially compromise the implant's surface properties and may affect long-term stability and performance.
Three units were distributed nationwide. The product was also distributed internationally to the Netherlands, Canada, Singapore, Spain, Sweden, and the UK. The recall affects primary and revision hip replacement patients, particularly those considered high risk for dislocation.
If you have received one of the recalled prostheses, consult your healthcare provider or surgeon. Patients with implanted devices should contact their surgeon to determine whether their implant is affected and whether any clinical action is needed.
The recalled product
- Product
- TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- prosthesis-defect
- implant-loosening
- dislocation-risk
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)
- UDI-DI: (01)07613327381023(17)290313(10) Lot Number: 14876553 14876552
Distribution
Distributed nationwide across the United States.
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