Hip replacement acetabular shell recalled for excessive deburring
Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER58F hip replacement acetabular shells due to excessive deburring. The manufacturing defect affects units distributed nationwide and internationally.
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 an FDA Class II recall affecting the structural integrity of an orthopedic implant. Although no injuries have been reported in the source text, the manufacturing defect affecting a critical hip replacement component poses a potential risk of harm and meets the criteria for High severity.
Plain-English summary
Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER58F acetabular shells (Catalog Number 742-11-58F, Lot Number 13927651) used in hip replacement surgery. The acetabular shell is the cup-shaped component of the hip replacement, indicated for use in primary and revision patients at high risk of hip dislocation.
The product may have excessive deburring that results in a smooth surface on the edge of the shell. This manufacturing defect could affect the performance and durability of the implant.
Affected devices were distributed nationwide and internationally to Netherlands, Canada, Singapore, Spain, Sweden, and the UK. Patients who have received this implant should contact their physician to discuss whether they need follow-up care or evaluation.
Physicians and patients should report any adverse events to the FDA MedWatch program.
The recalled product
- Product
- TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
- 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)07613327380811(17)290313(10) Lot Number: 13927651
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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