United Orthopedic Corporation recalls USTAR II Knee System Cemented curved stem, RHS, Non Coated with specific reference numbers and lot codes due to potential incorrect implant orientation.
Their is a potential that the implant curved stem may be oriented incorrectly.
United Orthopedic Corporation is recalling certain USTAR II Knee System cemented curved stems for possible incorrect orientation. This could affect surgical outcomes if the implant is not properly aligned during knee replacement procedures.
The implant curved stem may be oriented incorrectly during surgical installation, which could lead to improper knee alignment. This might cause complications such as pain, instability, or the need for additional surgery if the stem is not correctly positioned.
Patients who received the recalled USTAR II Knee System cemented curved stems (RHS, Non Coated) with the listed reference numbers or lot codes. Surgeons and medical staff who used these specific implants during procedures are most at risk.
Check the product reference numbers listed (e.g., PE25153109) or lot numbers (e.g., 15E198AA) on the implant packaging or documentation. The recall covers specific sizes and configurations of the cemented curved stem for right-hand side (RHS) use.
Review the reference numbers and lot codes on the implant packaging to confirm if it is part of the recall.
The recall is due to a potential that the implant curved stem may be oriented incorrectly, which could affect surgical outcomes.
The recall includes USTAR II Knee System cemented curved stems (RHS, Non Coated) with reference numbers like PE25153109 and lot numbers such as 15E198AA.
If you have the recalled implant, check the reference numbers and lot codes to confirm. The recall does not require immediate action but should be reviewed by your surgeon.
We’ve drafted a message you can send United Orthopedic Corporation to request your refund or repair — edit it as you like.
Subject: Recall Z-1216-2024 — United Orthopedic Corporation United Orthopedic Corporation Hello, I own a United Orthopedic Corporation that is covered by recall Z-1216-2024 from United Orthopedic Corporation. 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.
