The Recall Desk
HighFDA (Devices)·Z-2605-2021·Announced 2021-10-06

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.

What this means for you

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
Hazard
  • sterility-loss
  • contamination
  • water-damage

Distribution

Distributed nationwide across the United States.