TRIDENTII HEMI Hip Implant Acetabular Shell Deburring Defect Recall
Howmedica Osteonics is recalling the TRIDENTII HEMI CLUSTER54E hip implant due to excessive deburring on the acetabular shell edge that may affect implant performance. The recall involves 225 units distributed nationwide and internationally.
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 a FDA Class II recall of a medical implant with a manufacturing defect (excessive deburring on the acetabular shell edge) that could affect implant performance. No illnesses or injuries have been reported in the source text, making the hazard theoretical rather than actualized, which limits the classification to High per the rubric criteria.
Plain-English summary
The TRIDENTII HEMI CLUSTER54E is a hip implant manufactured by Howmedica Osteonics Corp., indicated for primary and revision patients at high risk of hip dislocation. A total of 225 units have been recalled.
The acetabular shell component may have excessive deburring, resulting in a smooth surface on the shell edge. This manufacturing defect could potentially compromise the implant's structural integrity and performance.
The affected units were distributed nationwide and internationally, including to the Netherlands, Canada, Singapore, Spain, Sweden, and the United Kingdom. Specific lot numbers involved are: 15293151, 15293153, 15293152, 15432252, 15432254, 15432451, 15432351, 15432251, 15432253, and 16265752.
The recalled product
- Product
- TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
- Manufacturer
- Howmedica Osteonics Corp.
- Category
- Medical Device — Hip Implant
- Hazard
- Affected units
- 225
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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