Device product

TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E

Z-1625-2024

February 27, 2024

Class II

Product summary

Firm: Howmedica Osteonics Corp.
Event: Event 94215
Status: Ongoing
Classification: Class II
Quantity: 225 units
Official record key: device-enforcement:Z-1625-2024

Official wording

Reason: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Code information: UDI-DI:(01)07613327380880(17)290313(10) Lot Number: 15293151 15293153 15293152 15432252 15432254 15432451 15432351 15432251 15432253 16265752

Distribution pattern: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell