FDAClass IIMay 1, 2024

TRIDENTII HEMI CLUSTER52E-Indicated for use in primary recall

TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E

Why was TRIDENTII HEMI CLUSTER52E-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)07613327380859(17)290313(10 Lot Number: 14875853 14875852

Product
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
Recalling firm
Howmedica Osteonics Corp.
Quantity
48 units
Distribution
Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Recall date
May 1, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls