TRIDENTII HEMI CLUSTER48D-indicated for use in primary recall
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
Why was TRIDENTII HEMI CLUSTER48D-indicated for use in primary recalled?
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: (01)07613327380903(17)290313(10) Lot Number: 14875651 15005253 16044255
- Product
- TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 45 units
- Distribution
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- Recall date
- May 1, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)