Signature Orthopedics Genius Knee Cemented Tibial Component Product Mix-Up Recall
Signature Orthopedics recalls Genius Knee Cemented Tibial Component due to product mix-up risk. Affected units have specific UDI and model numbers.
Lower-risk recall
Product mix up
Contact the company
What happened, in plain English
Signature Orthopedics is recalling Genius Knee Cemented Tibial Component knee replacement parts because of a product mix-up. This could lead to incorrect components being used in surgeries, potentially causing complications. Read more at govinfonow.com/recall/69357-signature-orthopedics-genius-knee-cemented-tibial-component-product-mix-up.
Source Summary by GovInfoNow · govinfonow.com/recall/69357-signature-orthopedics-genius-knee-cemented-tibial-component-product-mix-up · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0833-2019
Cite this page
“Signature Orthopedics Genius Knee Cemented Tibial Component Product Mix-Up Recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69357-signature-orthopedics-genius-knee-cemented-tibial-component-product-mix-up. Based on FDA recall #Z-0833-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0833-2019%22&limit=1).
Why it’s dangerous
A product mix-up means the wrong knee replacement component might be used in surgery. This could lead to incorrect fitting or complications during the procedure. The risk is primarily for surgical procedures where the component is installed.
Who’s affected
Patients who received this knee replacement component during surgery are likely affected. Surgeons and medical facilities using the product are at risk of using the wrong component.
How to tell if you have this one
Check for the UDI number 09348215020309 and model number 121-07-4004 on the product. The lot number 77A3F is also associated with this specific recall.
- Brand
Signature Orthopedics- 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
Terminated- Distribution
US Nationwide Distribution in the states of FL, NY, and TN
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0833-2019 | Genius Knee Cemented Tibial Component Product Usage: Knee replacement component; UDI # 09348215020309 Device Model # 121-07-4004 Lot # 77A3F | 10 |
| Z-0834-2019 | Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component; UDI # 09348215020330 Device Model # 121-07-3000 Lot # 788F7-1 | 3 |
What to do — step by step
Check Product Details
Look for the UDI number 09348215020309 and model number 121-07-4004 on the product.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide Distribution in the states of FL, NY, and TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, New York, Tennessee.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0833-2019 (December 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0833-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.