CLASS II ONGOING Device recall · Reported 1 May 2024 · FDA Enforcement Report
Tridentii Hemi CLUSTER54E- Indicated for use in primary recalled
Howmedica Osteonics is recalling Tridentii Hemi CLUSTER54E- Indicated for use in primary and revision patients at high, distributed nationwide in the US. The recall was initiated on 27 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1625-2024
- FDA event ID
- 94215
- Recalling firm
- Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Feb 2024
- FDA classified
- 25 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 27 Feb 2024 | Recall initiated by company | |
| 25 Apr 2024 | Classified by FDA | +58 days |
| 1 May 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Product as listed by the FDA
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
Where it was distributed
Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Questions about this recall
Why was it recalled?
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Which lots are affected?
UDI-DI:(01)07613327380880(17)290313(10) Lot Number: 15293151 15293153 15293152 15432252 15432254 15432451 15432351 15432251 15432253 16265752
Where was it sold?
Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 94215This product is part of a recall event; the main page for the event is Tridentii PSL CLUSTER58F-Indicated for use in primary recalled.
More recalls from Howmedica Osteonics
All 244| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio + Mobile Bearing Pcs 78-5-0910 System One Bipolar recalled | Howmedica Osteonics | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,110| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |