Signature Orthopedics recalls Genius Knee Cemented Tibial Component due to product mix-up risk. Affected units have specific UDI and model numbers.
Product mix up
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.
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.
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.
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.
Look for the UDI number 09348215020309 and model number 121-07-4004 on the product.
The recall is due to a product mix-up risk, not immediate danger. The hazard is that the wrong component might be used in surgery, potentially causing complications.
Check for the UDI number 09348215020309 and model number 121-07-4004 on the product. The lot number 77A3F is also associated with this recall.
The recall does not specify a remedy. Check with your surgeon or medical facility to determine if the product was used in your surgery.
We’ve drafted a message you can send Signature Orthopedics to request your refund or repair — edit it as you like.
Subject: Recall Z-0833-2019 — Signature Orthopedics Signature Orthopedics Hello, I own a Signature Orthopedics that is covered by recall Z-0833-2019 from Signature Orthopedics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
