Hip Implant Acetabular Shell Recalled for Manufacturing Defect
Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER50D hip implant shells due to excessive deburring that may create a smooth edge, potentially affecting implant fit. Affected 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: FDA Class II recall of a critical orthopedic medical device with a manufacturing defect that could affect implant function and stability. No illnesses or injuries have been reported to date.
Plain-English summary
Howmedica Osteonics Corp. is recalling the TRIDENTII HEMI CLUSTER50D acetabular shell component of hip implants due to a manufacturing defect. The acetabular shell may undergo excessive deburring during production, resulting in a smooth surface on the edge of the shell rather than the intended surface finish.
The product is indicated for use in primary and revision patients at high risk of hip dislocation. The smooth edge from excessive deburring may affect the proper fit and function of the implant.
The recall affects TRIDENTII HEMI CLUSTER50D units (Catalog Number 702-11-50D) with the following lot numbers: 14629051, 14628851, 15175654, and 15610452. These units were distributed nationwide in the United States and to the Netherlands, Canada, Singapore, Spain, Sweden, and the United Kingdom.
Patients who have received this implant should contact their healthcare provider to determine if their device is affected and discuss any necessary follow-up care.
The recalled product
- Product
- TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- manufacturing-defect
- hip-implant-defect
Distribution
Distributed nationwide across the United States.
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