Hip implant recalled for acetabular shell deburring defect
Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER48D hip implants (Lot 16311453) due to excessive deburring on the acetabular shell edge, a manufacturing defect.
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 for a structural manufacturing defect in a hip implant. The acetabular shell deburring defect constitutes a risk-of-harm product where no injuries have been reported in the source.
Plain-English summary
Howmedica Osteonics Corp. is recalling the TRIDENTII PSL CLUSTER48D hip implant (Catalog Number: 742-11-48D) due to a manufacturing defect.
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.
The affected products carry Lot Number 16311453 and were distributed in the United States and internationally in the Netherlands, Canada, Singapore, Spain, Sweden, and the United Kingdom.
Patients with this implant should consult their surgeon or healthcare provider regarding this recall. Healthcare facilities with remaining inventory of this lot number should stop use and contact Howmedica Osteonics Corp. for further information.
The recalled product
- Product
- TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
- 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)07613327380941(17)290313(10) Lot Number: 16311453
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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