United Orthopedic Corporation recalls USTAR II Knee System with cemented curved stem and RHS Ti Plasma Spray for potential incorrect implant orientation. Affected units have specific reference numbers and lot numbers.
Their is a potential that the implant curved stem may be oriented incorrectly.
United Orthopedic Corporation is recalling certain USTAR II Knee Systems because the curved stem may be oriented incorrectly. This could lead to improper joint alignment after surgery, potentially causing pain or complications during recovery.
The curved stem in the implant may be oriented incorrectly during surgery, which could result in improper joint alignment. This might cause pain, instability, or complications during the healing process after surgery.
Patients who received the recalled USTAR II Knee System implants between the specified dates and lot numbers are affected. Those with the specific reference numbers or UDI codes listed are most at risk.
Check if your USTAR II Knee System has reference numbers starting with PE25153109 to PE25151109 or the listed UDI codes and lot numbers. The product includes specific sizes like 9x125mm to 15x200mm.
Review your implant's reference numbers and UDI codes to confirm if it matches the recalled list.
The recall is due to a potential issue where the curved stem in the implant may be oriented incorrectly, which could lead to improper joint alignment after surgery.
Check your implant's reference numbers and UDI codes against the provided list to see if it's affected. If it is, contact United Orthopedic Corporation for further instructions.
The recall addresses a potential issue with implant orientation that could lead to pain or complications during recovery, but it does not pose an immediate risk of serious injury in normal use.
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-1217-2024 — United Orthopedic Corporation United Orthopedic Corporation Hello, I own a United Orthopedic Corporation that is covered by recall Z-1217-2024 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.
