Device recall: TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog…
Class II FDA enforcement event 94215. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Howmedica Osteonics Corp. started this device recall on 27 Feb 2024. The firm address in the FDA record is in Mahwah, NJ. FDA put the recall in Class II. FDA event 94215 has 12 product records. The first FDA enforcement report date is 1 May 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Recalling firm
Howmedica Osteonics Corp., Mahwah, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1621-2024 | TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B | 0 | Class II | Ongoing | 1 May 2024 |
| Z-1622-2024 | TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D | 45 units | Class II | Ongoing | 1 May 2024 |
| Z-1623-2024 | TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D | 0 | Class II | Ongoing | 1 May 2024 |
| Z-1624-2024 | TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E | 48 units | Class II | Ongoing | 1 May 2024 |
| Z-1625-2024 | TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E | 225 units | Class II | Ongoing | 1 May 2024 |
| Z-1626-2024 | TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F | 0 | Class II | Ongoing | 1 May 2024 |
| Z-1627-2024 | TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H | 0 | Class II | Ongoing | 1 May 2024 |
| Z-1628-2024 | TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D | 0 | Class II | Ongoing | 1 May 2024 |
| Z-1629-2024 | TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D | 0 | Class II | Ongoing | 1 May 2024 |
| Z-1630-2024 | TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E | 3 units | Class II | Ongoing | 1 May 2024 |
| Z-1631-2024 | TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F | 0 | Class II | Ongoing | 1 May 2024 |
| Z-1632-2024 | TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H | 0 | Class II | Ongoing | 1 May 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 12Median of the firm: 1
- Events of the firm on the register
- 48
Other events of the firm
Official channels
- FDA enforcement report Z-1621-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 94215. https://recallregister.com/fda/ii/94215/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- What quantity of product is in FDA event 94215?
- The event has 12 product records. The first record gives this quantity:
0
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.