Corin BIOLOX DELTA Ceramic Hip Implant Heads Recalled for Incorrect Size Labeling
Corin Ltd is recalling BIOLOX Delta Ceramic Hip Implant Heads nationwide due to size labeling errors. The 36XL size is labeled as 32XL and vice versa, which could result in implantation of an incorrectly sized component.
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 with no reported illnesses or injuries. The hazard—implant sizing mismatch—is a risk-of-harm situation where incorrect component sizing could compromise surgical outcome and necessitate revision surgery, meeting the rubric criterion for Score 3.
Plain-English summary
Corin Ltd is recalling BIOLOX Delta Ceramic Hip Implant Heads (size 36XL and 32XL, Lot 503150) due to incorrect labeling. The 36XL size is labeled as 32XL and vice versa.
This labeling error creates a risk that surgeons may implant an incorrectly sized component during hip replacement procedures. An implant component that does not match the intended size could compromise the fit and function of the prosthesis and may require revision surgery.
The recalled product was distributed nationwide to medical facilities in Florida, Georgia, Massachusetts, Michigan, Oklahoma, Pennsylvania, and Texas.
Consumers and healthcare providers who have received this product should contact Corin Ltd immediately. Surgeons should verify the actual component size matches the surgical plan before implantation. Patients who have received this implant should consult their surgeon to determine if any action is necessary.
The recalled product
- Product
- Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
- Manufacturer
- Corin Ltd
- Affected units
- 5
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 (2)
- UDI/DI (01) 0 5055196 96833 2
- Lot 503150
Distribution
Part of a larger recall action
This product is one of 2 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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