Signature Orthopedics recalls Genius Knee Cemented CR Femoral Component due to product mix-up risk. Affected units have UDI # 0934821:0330 and model 121-07-3000. No remedy specified in recall notice.
Product mix up
Signature Orthopedics is recalling Genius Knee Cemented CR Femoral Components because of a product mix-up. This could lead to using the wrong component during knee replacement surgery, which may cause complications.
A product mix-up means the wrong knee replacement component was used during surgery. This could lead to improper joint alignment or complications requiring additional surgery. The hazard is specific to the surgical context and not a general product risk.
Patients who have received this knee replacement component from Signature Orthopedics are affected. Surgeons and medical staff who used the recalled component during procedures are at highest risk.
Check for the UDI number 09348215020330 and model number 121-07-3000 on the component. The lot number 788F7-1 is also associated with this recall.
Look for the UDI number 09348215020330 and model number 121-07-3000 on the knee replacement component.
The recall notice does not specify any remedy for this product mix-up.
The recall notice does not provide specific action steps for affected users.
Check for the UDI number 09348215020330 and model number 121-07-3000 on the component.
We’ve drafted a message you can send Signature Orthopedics to request your refund or repair — edit it as you like.
Subject: Recall Z-0834-2019 — Signature Orthopedics Signature Orthopedics Hello, I own a Signature Orthopedics that is covered by recall Z-0834-2019 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.
