Corin BIOLOX Delta Mod Head hip implant components recall due to packaging damage
Corin Ltd is recalling Corin BIOLOX Delta Mod Head hip implant components due to packaging system damage that could result in loss of sterility or device contamination. Affected units were distributed nationwide to nine states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involving potential loss of sterility and contamination of an orthopedic implant component. No illnesses or injuries have been reported, and the hazard is theoretical without demonstrated patient harm.
Plain-English summary
Corin Ltd is recalling Corin BIOLOX Delta Mod Head components (REF 104.2805), which are used in hip replacement surgeries as part of the Trinity Acetabular System. The recall affects 4 units that were distributed nationwide to healthcare facilities in Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah, and Wisconsin.
The affected devices were packaged in a system that sustained physical and water damage, which could result in loss of sterility, device contamination, or physical damage to the components. Sterile medical implants must remain uncontaminated from the manufacturing facility through implantation to prevent infection and ensure proper function.
Healthcare facilities that received these devices should stop using them and contact Corin Ltd for instructions on return or replacement. Patients who may have received these implants should consult their physician.
The recalled product
- Product
- Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
- Manufacturer
- Corin Ltd
- Affected units
- 4
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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