Howmedica TRIDENTII PSL Cluster58F Hip Implant Recall: Smooth Acetabular Shell Risk
Howmedica recalls TRIDENTII PSL Cluster58F hip implants with potential smooth acetabular shell edges. This may cause dislocation in high-risk hip patients. Affected units have specific catalog and lot numbers.
Lower-risk recall
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Contact the company
What happened, in plain English
Howmedica is recalling TRIDENTII PSL Cluster58F hip implants for patients at high risk of hip dislocation. The recall is due to a potential smooth edge on the acetab: this could increase dislocation risk during surgery or recovery. Read more at govinfonow.com/recall/56049-howmedica-tridentii-psl-cluster58f-hip-implant-recall-smooth-acetabular-shell.
Source Summary by GovInfoNow · govinfonow.com/recall/56049-howmedica-tridentii-psl-cluster58f-hip-implant-recall-smooth-acetabular-shell · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1631-2024
Cite this page
“Howmedica TRIDENTII PSL Cluster58F Hip Implant Recall: Smooth Acetabular Shell Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56049-howmedica-tridentii-psl-cluster58f-hip-implant-recall-smooth-acetabular-shell. Based on FDA recall #Z-1631-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1631-2024%22&limit=1).
Why it’s dangerous
The acetabular shell may have excessive deburring, creating a smooth surface on the edge. This smooth edge could potentially increase the risk of dislocation during hip surgery or recovery for patients at high risk.
Who’s affected
Patients with high risk of hip dislocation who received this specific implant model. Those with the catalog number 742-11-58F and lot number 13927651 are most affected.
How to tell if you have this one
Check if your implant has catalog number 742-11-58F and lot number 13927651. This model is intended for primary and revision hip surgeries in high-risk patients.
- Brand
Howmedica- Product
TRIDENTII PSL CLUSTER58F- Category
Medical device
All 12 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| 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; UDI-DI: (01)07613327380897(17)290313(10) Lot Number: 14974852 | 0 |
| 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; UDI-DI: (01)07613327380903(17)290313(10) Lot Number: 14875651 15005253 16044255 | 45 units |
| 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; UDI-DI: (01)07613327381047(17)290313(10) Lot Number: 14629051 14628851 15175654 15610452 | 0 |
| 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; UDI-DI: (01)07613327380859(17)290313(10 Lot Number: 14875853 14875852 | 48 units |
| 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; UDI-DI:(01)07613327380880(17)290313(10) Lot Number: 15293151 15293153 15293152 15432252 15432254 15432451 15432351 15432251 15432253 16265752 | 225 units |
| 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; UDI-DI: (01)07613327380958(17)290313(10) Lot Number: 15854353 | 0 |
| 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; UDI-DI: (01)07613327380835(17)290313(10) Lot Number: 15445252 | 0 |
| 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; UDI-DI: (01)07613327380941(17)290313(10) Lot Number: 16311453 | 0 |
| 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; UDI-DI:(01)07613327381009(17)290313(10) Lot Number: 14593551 15432653 15432651 | 0 |
| 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; UDI-DI: (01)07613327381023(17)290313(10) Lot Number: 14876553 14876552 | 3 units |
| 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; UDI-DI: (01)07613327380811(17)290313(10) Lot Number: 13927651 | 0 |
| 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; UDI-DI: (01)07613327380927(17)290313(10) Lot Number: 15611151 | 0 |
What to do — step by step
Check Your Implant Details
Verify your implant's catalog number (742-11-58F) and lot number (13927651) to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury from this implant?
The recall is for potential increased dislocation risk in high-risk patients, but the hazard does not indicate a risk of serious injury in normal use.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1631-2024 (February 27, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1631-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.