Hip implant acetabular shell deburring defect triggers manufacturer recall
The TRIDENTII HEMI CLUSTER58F hip implant acetabular shell may have excessive deburring creating a smooth edge. Howmedica Osteonics Corp. is recalling affected units.
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 an orthopedic implant used in high-risk patients. No injuries have been reported, placing this at High (3) per the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Howmedica Osteonics Corp. is recalling the TRIDENTII HEMI CLUSTER58F hip implant due to a manufacturing defect in the acetabular shell component. Some affected units may have excessive deburring on the shell edge, resulting in a smooth surface.
The recalled implant is indicated for use in primary and revision patients at high risk of hip dislocation. Affected lots have been distributed nationwide and internationally to the Netherlands, Canada, Singapore, Spain, Sweden, and the United Kingdom.
Patients with questions about their implant should contact their healthcare provider or the manufacturer for guidance.
The recalled product
- Product
- TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
- Manufacturer
- Howmedica Osteonics Corp.
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)07613327380958(17)290313(10) Lot Number: 15854353
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.
See all 12 products in this recall →Related recalls
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