United Orthopedic Corporation recalls USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray with specific reference numbers 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 Hip System Press-Fit Curved Stem implants because they may be oriented incorrectly. This could lead to improper function of the hip replacement, potentially causing pain or complications after surgery.
The implant curved stem may be oriented incorrectly during surgery, which could lead to improper alignment of the hip joint. This might cause pain, instability, or complications after the implant is placed.
Patients who received the recalled USTAR II Hip System Press-Fit Curved Stem implants with the listed reference numbers or UDI codes. Surgeons and medical staff who used these specific implants during procedures are most at risk.
Check if your implant has reference numbers like PE11151211 (11x150mm) or UDI codes such as 04719872153894. The lot numbers listed in the recall also indicate specific batches to check.
Review your implant's reference numbers and UDI codes to confirm if they match the listed recall items.
The recall is due to a potential that the implant curved stem may be oriented incorrectly, which could lead to improper hip joint alignment.
Check your implant's reference numbers (e.g., PE11151211) or UDI codes (e.g., 04719872153894) against the list provided in the recall notice.
If your implant's reference numbers or UDI codes do not match the recalled items, you do not need to take any action.
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-1215-2024 — United Orthopedic Corporation United Orthopedic Corporation Hello, I own a United Orthopedic Corporation that is covered by recall Z-1215-2024 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.