Hip replacement acetabular shells recalled for deburring defect
Howmedica is recalling hip replacement acetabular shells that may have excessive deburring, resulting in a smooth surface on the shell edge. The recall affects devices 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 device recall with no reported illnesses or injuries. The hazard—excessive deburring causing a smooth surface on the acetabular shell edge—is a manufacturing defect in a high-risk implant device, meeting the rubric criterion for score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER64H hip replacement acetabular shells (Catalog Number 742-11-64H, Lot Number 15611151). The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell. The product is indicated for use in primary and revision hip replacement patients at high risk of hip dislocation.
The recalled shells were distributed nationwide and to the Netherlands, Canada, Singapore, Spain, Sweden, and the UK. The U.S. Food and Drug Administration classified this as a Class II recall.
The recalled product
- Product
- TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
- 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)07613327380927(17)290313(10) Lot Number: 15611151
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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