CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report
Trinity-i, diameter Taper Size 3, Non-Occluded Ti Plasma Shell recalled
Corin is recalling Corin Trinity-i, diameter Taper Size 3, Non-Occluded Ti Plasma Shell, 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-2605-2021
- 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
- Hip & Knee Implants
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-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular 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
Is Trinity-i, diameter Taper Size 3, Non-Occluded Ti Plasma Shell recalled?
Yes. Corin recalled Trinity-i, diameter Taper Size 3, Non-Occluded Ti Plasma Shell on 28 Jul 2021. The recall is Class II and its status is Terminated. Recall number Z-2605-2021.
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. Lot number 441120 was delivered to the consignee 7/23/2021 and 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.
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