The Recall Desk
HighFDA (Devices)·Z-2603-2021·Announced 2021-10-06

Corin TriFit TS Orthopedic Implant Recall Due to Packaging Damage and Sterility Loss

Corin Ltd is recalling Corin TriFit TS orthopedic implants due to packaging damage that may cause sterility loss and device contamination. The affected devices were shipped in July 2021 to multiple US 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: FDA Class II medical device recall with no reported illnesses or injuries. An orthopedic implant with potential loss of sterility and contamination represents a risk-of-harm product without yet-reported injury, meeting the High severity criterion.

Plain-English summary

Corin Ltd is recalling Corin TriFit TS, Size 8, Standard Tapered Stem (REF 694.0008) orthopedic implants. The recall affects 5 devices with potential damage to the packaging system that could result in loss of sterility or contamination of the devices.

The affected devices were delivered between July 22-26, 2021 to customers in Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah, and Wisconsin. Lot number 467870 was delivered on July 23 and July 26, 2021.

Patients and healthcare providers who may have received these devices should contact Corin Ltd for further guidance.

The recalled product

Product
Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
Manufacturer
Corin Ltd
Category
Medical Device — Orthopedic Implant
Hazard
  • sterility-loss
  • device-contamination
  • packaging-damage

Distribution

Distributed nationwide across the United States.

Related recalls

Same category