DJO EMPOWR KNEE Femoral Sizer Recall: Incorrect Assembly Risk
Encore Medical recalls DJO EMPOWR KNE: Incorrect assembly causes windows to face opposite direction. Check model 800-05-034 lot 326336L02 for affected units.
Lower-risk recall
Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
Contact the company
What happened, in plain English
Encore Medical is recalling DJO EMPOWR KNEE Femoral Sizer model 80: Incorrect assembly can cause the size indicators to face the wrong way, potentially leading to improper sizing. This does not pose a safety risk but requires verification of the assembly. Read more at govinfonow.com/recall/63299-djo-empowr-knee-femoral-sizer-recall-incorrect-assembly-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63299-djo-empowr-knee-femoral-sizer-recall-incorrect-assembly-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1524-2021
Cite this page
“DJO EMPOWR KNEE Femoral Sizer Recall: Incorrect Assembly Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63299-djo-empowr-knee-femoral-sizer-recall-incorrect-assembly-risk. Based on FDA recall #Z-1524-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1524-2021%22&limit=1).
Why it’s dangerous
The product has a subcomponent that can be assembled incorrectly by a vendor, causing the size indicators to face the opposite direction. This may lead to improper sizing during medical procedures but does not cause injury or damage.
Who’s affected
Patients using the DJO EMPOWR KNEE Femoral Sizer model 800-05-034 lot 326336L02 are affected. Those who have the product but are not using it for medical procedures are at minimal risk.
How to tell if you have this one
Check for model number 800-05-034 and lot number 326336L02 on the product. The recall applies to the DJO EMPOWR KNEE Femoral Sizer sold by Encore Medical.
- Brand
Encore Medical- Category
Medical device
What to do — step by step
Check Product Details
Verify the model number 800-05-034 and lot number 326336L02 on the DJO EMPOWR KNEE Femoral Sizer.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “U.S.: FL, IN, and MN O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Indiana, Minnesota.
Recall timeline
FDA published this recall 3 months 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.
Questions people ask
What should I do if I have this product?
Check the model and lot numbers to see if it is affected; no action is needed if it is not in the recall list.
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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-1524-2021 (February 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1524-2021 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.