Corin BIOLOX DELTA ceramic hip replacement heads mislabeled with incorrect sizes
Corin Ltd is recalling BIOLOX DELTA ceramic hip replacement heads because some units are labeled with incorrect sizes. The recall affects 12 units distributed in seven U.S. 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: This is an FDA Class II recall of an orthopedic implant with a critical labeling error that could result in implantation of an incorrectly sized prosthetic. No illnesses or injuries have been reported, but mismatched prosthetic sizing poses significant risk of harm including improper joint function and potential revision surgery.
Plain-English summary
Corin Ltd is recalling BIOLOX DELTA MOD HEAD ceramic prosthetics, size 36mm extra long with 8mm offset (REF 104.3615, Lot 503151), due to a labeling error. Specifically, units labeled as size 32XL are actually size 36XL, and units labeled as size 36XL are actually size 32XL.
The 12 recalled units were distributed nationwide to medical facilities in Florida, Georgia, Massachusetts, Michigan, Oklahoma, Pennsylvania, and Texas. The labeling error could result in implantation of an incorrectly sized prosthetic head, potentially affecting surgical outcomes and requiring revision procedures.
Patients who have received these prosthetics should contact their surgeon or healthcare provider to confirm that the correct size was implanted. Corin Ltd has notified affected distributors and healthcare facilities of the recall.
The recalled product
- Product
- Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
- Manufacturer
- Corin Ltd
- Hazard
- Affected units
- 12
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 96834
- Lot 503151
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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