TRIDENTII HEMI hip implant recalled for acetabular shell manufacturing defect
Howmedica Osteonics is recalling the TRIDENTII HEMI CLUSTER48D hip implant because the acetabular shell may have excessive deburring, resulting in a smooth surface on the shell edge.
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 recall with a manufacturing defect in a hip implant acetabular shell component. No illnesses or injuries have been reported, but the excessive deburring defect represents a risk-of-harm condition without reported adverse events.
Plain-English summary
The TRIDENTII HEMI CLUSTER48D hip implant, manufactured by Howmedica Osteonics Corp., is being recalled due to a manufacturing defect. The acetabular shell component may have excessive deburring, resulting in a smooth surface on the edge of the shell.
45 units have been distributed in the United States and to international locations including the Netherlands, Canada, Singapore, Spain, Sweden, and the United Kingdom. The affected lot numbers are 14875651, 15005253, and 16044255.
Patients who have received this implant should consult their healthcare provider about this recall. Healthcare providers should review the recall information and determine appropriate actions for patients who received affected units.
The recalled product
- Product
- TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 45
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)07613327380903(17)290313(10) Lot Number: 14875651 15005253 16044255
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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