Corin TriIFit TS Hip Prosthesis Component Recall: Size Labeling Mix-Up
Corin recalls hip prosthesis components with incorrect size labels that could lead to improper fitting. Affected units have a specific lot number and model.
Lower-risk recall
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
Contact the company
What happened, in plain English
Corin is recalling hip prosthesis components that were mislabeled between two sizes. This could cause improper fitting if used in surgery, but the recall is for labeling errors, not safety risks. Read more at govinfonow.com/recall/62597-corin-triifit-ts-hip-prosthesis-component-recall-size-labeling-mix.
Source Summary by GovInfoNow · govinfonow.com/recall/62597-corin-triifit-ts-hip-prosthesis-component-recall-size-labeling-mix · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1850-2021
Cite this page
“Corin TriIFit TS Hip Prosthesis Component Recall: Size Labeling Mix-Up.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62597-corin-triifit-ts-hip-prosthesis-component-recall-size-labeling-mix. Based on FDA recall #Z-1850-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1850-2021%22&limit=1).
Why it’s dangerous
The components were labeled incorrectly between two sizes (TriFit TS size 2 and TriFit CF size 7). This mismatch could lead to improper fitting during surgery if the wrong size is used, potentially causing complications.
Who’s affected
Patients who received the recalled hip prosthesis components during surgery are likely affected. Surgeons and medical facilities that used these components are at risk of improper fitting.
How to tell if you have this one
Check for the lot number 465498 on the component. The product is a Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002 hip prosthesis component.
- Brand
Corin- Category
Medical device
All 2 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
Terminated- Distribution
US Nationwide distribution in the state of TX.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1850-2021 | Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.; Lot Number 465498 | 4 units |
| Z-1851-2021 | Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.; Lot Number 467881 | 1 unit |
What to do — step by step
Verify Component Label
Check the lot number on the component; affected units have lot number 465498.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury?
The recall addresses labeling errors, not safety risks. There is no indication of serious injury from this issue.
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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-1850-2021 (May 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1850-2021 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.