TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
Reported: May 1, 2024 Initiated: February 27, 2024 #Z-1630-2024
Product Description
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
Reason for Recall
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 3 units
- Distribution
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E. Recalled by Howmedica Osteonics Corp.. Units affected: 3 units.
Why was this product recalled? ▼
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2024. Severity: Moderate. Recall number: Z-1630-2024.
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