The Recall Desk
HighFDA (Devices)·Z-2604-2021·Announced 2021-10-06

Corin Trinity Bone Screws Recalled for Potential Packaging Damage and Sterility Loss

Corin Ltd is recalling specific lots of Trinity Acetabular System bone screws due to potential packaging damage that could result in loss of sterility or device 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 an FDA Class II recall of a surgical implant component where sterility loss or contamination is possible, representing a risk-of-harm product. No illnesses or injuries have been reported in the source, and the hazard is described as potential rather than confirmed.

Plain-English summary

Corin Ltd is recalling two models of Corin Trinity Screw components used in the Trinity Acetabular System: the 6.5mm diameter 35mm length screw (REF 321.035, Lot 481070) and the 6.5mm diameter 50mm length screw (REF 321.050, Lot 478892). The screws are sterile cancellous bone screws used in orthopedic surgery.

The packaging system on these devices has potential physical and water damage that could result in device damage, loss of sterility, or contamination. Six units were distributed nationwide to healthcare facilities in Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah, and Wisconsin. The affected products were delivered between July 22-26, 2021.

Affected healthcare providers should contact Corin Ltd for guidance on the recalled products. Patients who have received these implants should consult with their healthcare provider if they have concerns about their device.

The recalled product

Product
Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System.
Manufacturer
Corin Ltd
Category
Medical Device — Orthopedic Implant
Hazard
  • loss-of-sterility
  • 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)

  • and Model 321.050 - Lot number 478892 was delivered 7/23/2021.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category