Hip Implant Acetabular Shell May Have Excessive Deburring Manufacturing Defect
Howmedica Osteonics Corp. is recalling TRIDENTII HEMI CLUSTER66H hip implants because the acetabular shell may have excessive deburring, creating a smooth surface on the edge of the shell.
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 Class II medical device recall for a manufacturing defect affecting an orthopedic implant used in high-risk patients. The excessive deburring may impact device fit or function. No adverse events have been reported. Per the rubric, this qualifies as High (3): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling TRIDENTII HEMI CLUSTER66H hip implants (Catalog Number 702-11-66H), which are indicated for primary and revision patients at high risk of hip dislocation. The acetabular shell component may have excessive deburring, resulting in a smooth surface on the edge of the shell.
The recalled implants were distributed nationwide and internationally, including to the Netherlands, Canada, Singapore, Spain, Sweden, and the United Kingdom. The recall includes Lot Number 15445252, identified by UDI-DI (01)07613327380835(17)290313(10).
This is a Class II medical device recall issued by the FDA.
The recalled product
- Product
- TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
- Manufacturer
- Howmedica Osteonics Corp.
- Category
- Medical Device — Hip Implant
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)07613327380835(17)290313(10) Lot Number: 15445252
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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