Corin BIOLOX Delta Head Recall: Size Labeling Error
Corin recalls BIOLOX Delta ceramic heads with size labeling error that may cause incorrect fit. Affected units have size 36XL labeled as 32XL and vice versa.
Lower-risk recall
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
Contact the company
What happened, in plain English
Corin is recalling BIOLOX Delta ceramic heads that have a size labeling error. This could lead to incorrect fitting, which might cause improper function or damage. Read more at govinfonow.com/recall/59484-corin-biolox-delta-head-recall-size-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/59484-corin-biolox-delta-head-recall-size-labeling-error · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0727-2023
Cite this page
“Corin BIOLOX Delta Head Recall: Size Labeling Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59484-corin-biolox-delta-head-recall-size-labeling-error. Based on FDA recall #Z-0727-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0727-2023%22&limit=1).
Why it’s dangerous
The size labels on the heads are swapped: size 36XL is labeled as 32XL and vice versa. This could lead to incorrect fitting, which might cause improper function or damage to the head or the system it's used with.
Who’s affected
Users of Corin BIOLOX Delta ceramic heads with the specific model and lot number are affected. Those who have the heads labeled incorrectly are most at risk.
How to tell if you have this one
Check for the model number 036mm EX LONG +8mm, REF 104.3615 with UDI/DI (01) 0 5055196 96834 and Lot 503151. The size labels may show 36XL as 32XL and vice versa.
- Brand
Corin- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0726-2023 | Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215; UDI/DI (01) 0 5055196 96833 2, Lot 503150 | 5 units |
| Z-0727-2023 | Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615; UDI/DI (01) 0 5055196 96834, Lot 503151 | 12 units |
What to do — step by step
Check Labeling
Verify the size labels on the head: size 36XL should be labeled as 36XL, not 32XL.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
FDA distribution: “US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia, Massachusetts, Michigan, Oklahoma, Pennsylvania, Texas.
Recall timeline
FDA published this recall 50 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0727-2023 (November 8, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0727-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.