Corin Trinity-i Acetabular Components Recalled Due to Packaging Damage
Corin Ltd is recalling Corin Trinity-i acetabular components (50mm diameter, Taper Size 3) distributed nationwide due to potential physical and water damage to the packaging system, which may compromise device sterility or cause contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving potential loss of sterility on surgical implants, classified as a risk-of-harm product. No illnesses or injuries have been reported, and the hazard is based on potential packaging damage rather than confirmed failure. Per the rubric, recalls with theoretical hazards and no reported harm score at most 3 (High).
Plain-English summary
Corin Ltd is recalling 50mm diameter Corin Trinity-i acetabular components (Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350) used in hip replacement surgery as part of the Trinity Acetabular System. Two units have been recalled.
The packaging system on the devices may have sustained physical or water damage, which could result in loss of device sterility or contamination. For surgical implants, compromised sterility presents a patient safety risk if the device is implanted.
The recalled units were distributed nationwide to healthcare facilities in Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah, and Wisconsin. The affected lot number is 441120, with shipments delivered between July 22–26, 2021.
The recalled product
- Product
- 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.
- Manufacturer
- Corin Ltd
- Affected units
- 2
Distribution
Part of a larger recall action
This product is one of 10 recalled by Corin Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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