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Howmedica Osteonics Corp. Recall 94215

Description: TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D

Howmedica Osteonics Corp. Recall 94215 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1628-2024
Event ID94215
Event DescriptionTRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
Product TypeDevices
DistributionNationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Recall ReasonThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Device Classification20240501
Device Code InfoUDI-DI: (01)07613327380941(17)290313(10) Lot Number: 16311453
Center Classification Date20240425
Recall Initiation Date20240227
Recalling FirmHowmedica Osteonics Corp.
Initial Notification Letter
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