Lower riskMedical device recall · FDA · Published October 31, 2022
Corin Unity Total Knee System Recall: Packaging Damage Risk
Corin recalls Unity Total Knee System (Model 112.040.06) due to potential packaging damage risking device sterility. Affected patients should contact Corin for guidance.
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
Take action
Contact the company
📍Recalling firmCorin LtdUnit 1-57-8, Corinium Centre · Cirencester, United Kingdom
✎ GovInfoNow plain-language explainer
Corin is recalling its Unity Total Knee System (model 112.040.06) because the internal packaging might be damaged, which could harm the device or compromise its sterility. This is serious for patients who have received this specific model for knee replacements. Read more at govinfonow.com/recall/59793-corin-unity-total-knee-system-recall-packaging-damage-risk.
“Corin Unity Total Knee System Recall: Packaging Damage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59793-corin-unity-total-knee-system-recall-packaging-damage-risk. Based on FDA recall #Z-0273-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0273-2023%22&limit=1).
The FDA announced on October 31, 2022, that Corin Ltd is recalling the Unity Total Knee System due to potential damage to internal packaging blisters that may compromise sterility. The recall affects four devices distributed in New Jersey, Puerto Rico, South Africa, and France.
How to tell if you have it
Brand: Corin
Product: Unity Total Knee System
Model Number: 112.040.06
Lot Number: 504337
The hazard
The internal packaging system for the devices may have damage to the blisters, potentially damaging the device or compromising the sterility of the packaging.
Context
GovInfoNow's records show Corin Ltd has issued seven other recalls since January 25, 2021. Other recent recalls include a Unity Total Knee System recall for incorrect labeling risk on October 13, 2023, and a BIOLOX Delta Head recall for size labeling error on November 8, 2022.
How to tell if you have this one
Check for the model number 112.040.06 on the packaging. This product was sold with lot number 504337.
Brand
Corin
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Corin
Patients should contact Corin directly for guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.” 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 terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0273-2023 (October 31, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0273-2023 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.