CLASS II ONGOING Device recall · Reported 8 Nov 2023 · FDA Enforcement Report
Unity Total Knee System recalled by Corin
Corin is recalling Unity Total Knee System, distributed in Illinois, Michigan, Texas. The recall was initiated on 13 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0214-2024
- FDA event ID
- 93144
- Recalling firm
- Corin, Cirencester, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Oct 2023
- FDA classified
- 2 Nov 2023
- Reported
- 8 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 13 Oct 2023 | Recall initiated by company | |
| 2 Nov 2023 | Classified by FDA | +20 days |
| 8 Nov 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Product as listed by the FDA
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Where it was distributed
US: MI, TX, IL
Questions about this recall
Is Unity Total Knee System recalled?
Yes. Corin recalled Unity Total Knee System on 13 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0214-2024.
Why was it recalled?
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.
Which lots are affected?
UDI/DI 05055343872505, Lot Number 532405.
Where was it sold?
US: MI, TX, IL
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Corin
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Unity CR Femur Right, Size recalled by Corin | Corin | Labeling Errors | IL, MI, TX |
| Device | CLASS II | Biolox Delta Mod Head, Ex Long + recalled by Corin | Corin | Other | Nationwide |
| Device | CLASS II | Biolox Delta Mod Head Ex Long + recalled by Corin | Corin | Other | Nationwide |
| Device | CLASS II | Unity Total Knee System recalled by Corin | Corin | Sterility | Nationwide |
| Device | CLASS II | TaperFit Stem, Size 0 Offset recalled by Corin | Corin | Other | NJ |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |