United Orthopedics recalls USTAR II Knee System Segment Part (Catalog #2915-1025) due to concentricity and fatigue testing failures. Affected units may not meet safety standards.
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
United Orthopedics is recalling a specific knee system segment part because it doesn't meet safety standards for concentricity and fatigue testing. This could lead to improper function or failure during use.
The knee system segment part fails to meet concentricity specifications and dynamic fatigue testing requirements. This means it may not function properly under stress or could fail during use, potentially causing improper joint movement or complications.
Patients who received this specific knee system segment part (RHS, 25 mm length, Catalog #2915-1025) are affected. Surgeons and medical staff using this part during procedures are at risk.
Check for the catalog number 2915-1025 on the product label. The UDI code is 04719872148197 and lot code 19E272H. This part was sold with the USTAR II Knee System.
Look for the catalog number 2915-1025 on the product label.
The recall is due to the product not meeting safety standards for concentricity and fatigue testing, but the official notice does not specify a risk of serious injury or death.
The official recall notice does not provide specific action steps for affected users.
Check for the catalog number 2915-1025 on the product label, UDI code 04719872148197, and lot code 19E272H.
We’ve drafted a message you can send United Orthopedics to request your refund or repair — edit it as you like.
Subject: Recall Z-0110-2022 — United Orthopedics United Orthopedics Hello, I own a United Orthopedics that is covered by recall Z-0110-2022 from United 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.
