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
- Affected units
- 2
Distribution
Part of a larger recall action
This product is one of 10 recalled by Corin Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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