The Recall Desk
HighFDA (Devices)·Z-2609-2021·Announced 2021-10-06

Corin MetaFix Hip Stem Recalled Due to Potential Packaging Damage

Corin Ltd is recalling Corin MetaFix Hip Stem, Size 1 devices due to potential physical and water damage to packaging that could compromise device sterility and 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: FDA Class II classification applies with no reported illnesses or injuries. The hazard is potential sterility loss and contamination, which represents theoretical risk to a medical implant rather than confirmed harm. Per the rubric, risk-of-harm products without reported injury are scored at 3.

Plain-English summary

Corin Ltd is recalling the Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem (REF 579.0201). Two units were involved in this recall. The affected devices were delivered between July 22-26, 2021, with lot number 476399 delivered on July 22-23, 2021.

The packaging system on these devices may sustain physical and water damage, potentially resulting in device damage, loss of sterility, or contamination. These defects could compromise the safety and effectiveness of the hip stem implants.

The devices were distributed nationwide to the following states: Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah, and Wisconsin.

Patients or healthcare providers with these devices should contact Corin Ltd for further guidance regarding this recall.

The recalled product

Product
Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.
Manufacturer
Corin Ltd
Category
Medical Device — Orthopedic Implant
Hazard
  • loss-of-sterility
  • contamination
  • package-damage

Distribution

Distributed nationwide across the United States.

Related recalls

Same category