Hip implant acetabular shell manufacturing defect recall affects patients
Howmedica Osteonics Corp. is recalling TRIDENTII HEMI CLUSTER44B hip implants due to excessive deburring on the acetabular shell edge. The recalled lot was distributed nationwide and internationally.
What this means for you
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 FDA Class II recall involving a manufacturing defect on a high-risk medical device (hip implant) with no reported injuries or illnesses. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Howmedica Osteonics Corp. is recalling the TRIDENTII HEMI CLUSTER44B hip implant (Catalog Number 702-11-44B), which is indicated for primary and revision hip replacement in patients at high risk of hip dislocation. The recall was issued because the acetabular shell component may have excessive deburring, resulting in a smooth surface on the edge of the shell.
The affected units have Lot Number 14974852 and were distributed nationwide and internationally to the Netherlands, Canada, Singapore, Spain, Sweden, and the United Kingdom.
Patients who have received this implant should contact their healthcare provider or surgeon to discuss whether they may be affected by this recall. Healthcare providers should cease distribution of units from the recalled lot immediately.
The recalled product
- Product
- TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- manufacturing-defect
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)07613327380897(17)290313(10) Lot Number: 14974852
Distribution
Distributed nationwide across the United States.
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