Z-1631-2024 Class II Ongoing
FDA device recall Z-1631-2024 was initiated by Howmedica Osteonics Corp. on Feb 27, 2024 and is designated Class II. Reason for recall: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell The recall status is ongoing. Affected quantity: 0.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- Feb 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0
Product Description
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
Reason for Recall
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Distribution Pattern
Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Code Information
UDI-DI: (01)07613327380811(17)290313(10) Lot Number: 13927651
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1631-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026