TRIDENTII HEMI hip prosthesis recalled for manufacturing defect
Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER52E hip prostheses due to excessive deburring on the acetabular shell. The defect may increase risk of hip dislocation in high-risk patients.
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: FDA Class II medical device recall involving a manufacturing defect on a hip prosthesis indicated for high-risk hip dislocation patients. No illnesses or injuries have been reported, qualifying this as a risk-of-harm recall with a theoretical hazard.
Plain-English summary
Howmedica Osteonics Corp. is recalling TRIDENTII HEMI CLUSTER52E hip prostheses (acetabular shells for primary and revision hip replacement surgery). The recall affects 48 units distributed nationwide and internationally to the Netherlands, Canada, Singapore, Spain, Sweden, and the UK.
The acetabular shell may have excessive deburring, which creates a smooth surface on the edge of the shell. This defect was identified as a manufacturing issue that could affect device performance in patients at high risk of hip dislocation.
Patients and healthcare providers with affected devices should contact Howmedica Osteonics Corp. for guidance. The FDA has classified this as a Class II recall. Affected lot numbers are 14875853 and 14875852.
The recalled product
- Product
- TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
- Manufacturer
- Howmedica Osteonics Corp.
- Category
- Medical Device — Hip prosthesis
- Affected units
- 48
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)07613327380859(17)290313(10 Lot Number: 14875853 14875852
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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