Corin Unity Total Knee System Recall: Incorrect Labeling Risk
Corin recalls Unity Total Knee System model 112.001.34 with batch numbers 529803-532405 due to potential incorrect labeling of knee implant sizes.
Lower-risk recall
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
Contact the company
What happened, in plain English
Corin is recalling a specific model of total knee replacement implants because some units may have the wrong size label. This could lead to improper fitting during surgery, which might cause complications for patients. Read more at govinfonow.com/recall/57070-corin-unity-total-knee-system-recall-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/57070-corin-unity-total-knee-system-recall-incorrect-labeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0214-2024
Cite this page
“Corin Unity Total Knee System Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57070-corin-unity-total-knee-system-recall-incorrect-labeling-risk. Based on FDA recall #Z-0214-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0214-2024%22&limit=1).
Why it’s dangerous
The recall involves a labeling error where size 6 implants might be labeled as size 7 and vice versa. This could result in the wrong implant size being used during surgery, potentially causing improper joint function or complications.
Who’s affected
Patients who received the Unity Total Knee System model 112.001.34 with batch numbers 529803 to 532405 are affected. Surgeons and medical facilities using these implants are at risk of administering incorrect sizes during procedures.
How to tell if you have this one
Check for the model number 112.001.34 on the implant packaging. Look for batch numbers 529803 through 532405 on the implant's documentation or label.
- 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
Ongoing- Distribution
US: MI, TX, IL
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0213-2024 | Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty; UDI/DI: (05055343872499, Lot Number: 529803. | 3 units |
| Z-0214-2024 | Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty; UDI/DI 05055343872505, Lot Number 532405. | 1 units |
What to do — step by step
Check Implant Labels
Verify the batch number on the implant's documentation to confirm it is not in the range 529803 to 532405.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “US: MI, TX, IL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Michigan, Texas.
Recall timeline
FDA published this recall 26 days 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.
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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-0214-2024 (October 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0214-2024 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.