Exactech BIOLOX Delta Femoral Head Recall: Incorrect Labeling Risk
Exactech recalls specific hip prosthesis components due to incorrect labeling that could lead to improper fit. Affected units have serial numbers 6465619-6465640 and 6465642-6465648.
Lower-risk recall
Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
Contact the company
What happened, in plain English
Exactech is recalling certain hip replacement femoral heads that were labeled incorrectly. This could cause improper fit during surgery if used with the wrong size component. Read more at govinfonow.com/recall/62281-exactech-biolox-delta-femoral-head-recall-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62281-exactech-biolox-delta-femoral-head-recall-incorrect-labeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2251-2021
Cite this page
“Exactech BIOLOX Delta Femoral Head Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62281-exactech-biolox-delta-femoral-head-recall-incorrect-labeling-risk. Based on FDA recall #Z-2251-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2251-2021%22&limit=1).
Why it’s dangerous
The recalled femoral heads were labeled as 170-36-00 (36mm +0) but were actually marked as 170-36-03 (36mm +3.5). This labeling error could lead to using the wrong size component during hip replacement surgery, potentially causing improper fit.
Who’s affected
Patients who received hip replacements using the recalled Exactech BIOLOX Delta Femoral Head components (serial numbers 6465619-6465640 and 6465642-6465648) are affected. Surgeons and medical facilities that used these components during procedures are most at risk.
How to tell if you have this one
Check if your hip prosthesis has the serial numbers 6465619-6465640 or 6465642-6465648. The product was labeled as 170-36-03 but marketed as 170-36-00.
- Brand
Exactech- 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
Completed- Distribution
US Nationwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2250-2021 | Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.; Serial Numbers: 6465589-6465618; 6465641 | 29 devices |
| Z-2251-2021 | Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.; Serial Numbers: 6465619-6465640; 6465642-6465648 | 30 devices |
What to do — step by step
Check Your Serial Numbers
Identify if your hip prosthesis has serial numbers 6465619-6465640 or 6465642-6465648.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
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-2251-2021 (June 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2251-2021 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.