The Recall Desk
HighFDA (Devices)·Z-2608-2021·Announced 2021-10-06

Corin Trinity Dual Mobility Hip Implant Components Recalled for Sterility Loss Risk

Corin Ltd is recalling specific Trinity Dual Mobility hip implant components due to packaging damage that may compromise sterility. The affected products were distributed to medical facilities in nine states.

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 an FDA Class II medical device recall involving sterile implantable hip components. While no illnesses or injuries have been reported, loss of sterility on implantable devices poses a risk of harm to patients.

Plain-English summary

Corin Ltd is recalling two specific models of the Trinity Dual Mobility hip implant system: the Trinity Dual Mobility Size 4 CoCr Liner (REF 321.04.540) and the Dual Mobility Size 4 insert/28 head (REF 325.04.042). Both products are sterile, implantable components of hip replacement systems.

The packaging system on these devices has potential for physical and water damage, which could result in damage to the devices, loss of sterility, or contamination.

The affected products were distributed to medical facilities in Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah, and Wisconsin. Specific lot numbers (478880 for Model 321.04.540 and 480567 for Model 325.04.042) were delivered on July 26, 2021.

Patients or healthcare providers who received implants from these specific lot numbers should contact Corin Ltd or their healthcare provider to discuss any concerns. The FDA is monitoring this recall.

The recalled product

Product
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.
Manufacturer
Corin Ltd
Category
Medical Device — Orthopedic Implants
Hazard
  • sterility-loss
  • contamination
  • packaging-damage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model 325.04.042- Lot number 480567 delivered 7/26/2021.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category