Unity Total Knee SystemRecalls & reported problems across all models
Corin Ltd · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Unity Total Knee System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 2
We found 5 models of Unity Total Knee System by Corin Ltd in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Jul 31, 2026 and Sep 29, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Unstable” (1 report).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Unity Total Knee System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 13, 2023Open, Classified
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.
Z-0214-2024 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 13, 2023Open, Classified
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.
Z-0213-2024 · Root cause: Process change control · Recall details · FDA record ↗
Most reported Unity Total Knee System problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Unstable1
Patient problems
- Unspecified Infection2
- Joint Laxity1
Unity Total Knee System models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Unity Total Knee System 112.001.32PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Unity Total Knee System 112.001.34PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Unity Total Knee System 112.014.82PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Unity Total Knee System 112.016.85PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Unity Total Knee System 1125182Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
Recent Unity Total Knee System adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Unity Revision of the CR Insert after approx. 4 years due to infection (OmniBotics used in primary).
Patient problems: Unspecified Infection
MAUDE report 50927734 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
Unity revision of the insert after approximatively 3 months due to infection. (Apollo used in primary surgery)
Patient problems: Unspecified Infection
MAUDE report 50851966 ↗InjuryJul 31, 2026Unstable
Unity revision of the PS Insert after approx. 2 years due to instability.
Patient problems: Joint Laxity
MAUDE report 50098398 ↗
Other Corin Ltd products
All Corin Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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