CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report
Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner recalled
Corin is recalling Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, distributed nationwide in the US. The recall was initiated on 28 Jul 2021 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-2608-2021
- FDA event ID
- 88589
- Recalling firm
- Corin, Cirencester, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jul 2021
- FDA classified
- 30 Sep 2021
- Reported
- 6 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 28 Jul 2021 | Recall initiated by company | |
| 30 Sep 2021 | Classified by FDA | +64 days |
| 6 Oct 2021 | 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
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 42 insert/28 head, REF 325.04.042, Sterile; both are components of the Trinity Dual Mobility System.
Where it was distributed
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
Nationwide ArizonaCaliforniaFloridaIllinoisOklahomaPennsylvaniaTexasUtahWisconsin
Questions about this recall
Why was it recalled?
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Which lots are affected?
The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 321.04.540 - Lot number 478880 delivered 7/26/2021; Model 325.04.042- Lot number 480567 delivered 7/26/2021.
Where was it sold?
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
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.
Other products in this recall event
9 other products · FDA event 88589This product is part of a recall event; the main page for the event is Unity Knee CS Insert, Size 5 /, Fixed Condylar Stabilised - Uhmwpe recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Unity Knee CS Insert, Size 5 /, Fixed Condylar Stabilised - Uhmwpe recalled | Corin | Sterility | Nationwide | |
| CLASS II | Biolox Delta Mod Head, diameter Medium, 12/14 Taper recalled by Corin | Corin | Sterility | Nationwide | |
| CLASS II | MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem recalled | Corin | Sterility | Nationwide | |
| CLASS II | TriFit TS, Size 8, Standard Tapered Stem recalled by Corin | Corin | Sterility | Nationwide | |
| CLASS II | Unity Knee Patella, Size 3 /, Centered Dome 3 Peg-uhmwpe recalled | Corin | Sterility | Nationwide | |
| CLASS II | Unity Knee Augments, Size 5, 6 & 7 / Thick recalled by Corin | Corin | Sterility | Nationwide | |
| CLASS II | Trinity-i, diameter Taper Size 3, Non-Occluded Ti Plasma Shell recalled | Corin | Sterility | Nationwide | |
| CLASS II | Trinity Liner Ecima, diameter Neutral Offset, Taper Size recalled | Corin | Sterility | Nationwide | |
| CLASS II | Trinity Screw, diameter Length, Cancellous Bone Screw recalled by Corin | Corin | Sterility | Nationwide |
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 | Unity Total Knee System 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 |
Other Wheelchairs, Beds & Lifts recalls
All 172| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Quantum Rehab Quantum 4Front 2HD recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge 2.0 (ilevel) recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum rehab Q6 Edge recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |