Smith & Nephew recalls R3 Acetabular Shells with out of specification dimensions due to manufacturing error. Affected units include specific sizes and lot numbers. Consumers should contact for details.
A manufacturing error resulted in out of specification R3 Acetabular Shells
Smith & Nephew is recalling certain R3 Acetabular Shells that were manufactured with out of specification dimensions due to a manufacturing error. This could lead to improper fit and potential complications during hip replacement surgery.
The recall is for R3 Acetabular Shells that were manufactured with dimensions outside the specified range. This could result in improper fit during hip replacement surgery, potentially leading to complications such as dislocation or instability of the implant.
Orthopedic surgeons and patients who have received the recalled R3 Acetabular Shells (specific sizes and lot numbers listed in the recall). Patients with hip replacements using these components are most at risk.
Check the product size (42mm to 60mm) and lot number on the shell. The specific lot numbers and product codes are listed in the recall notice for each size.
Identify the size (42mm to 60mm) and lot number from the product label to determine if it is affected.
Smith & Nephew R3 No Hole Hemispherical Stiktite Coated Shells in sizes 42mm to 60mm with specific lot numbers listed in the recall.
Check the size (42mm to 60mm) and lot number on the shell. The affected lot numbers are listed in the recall notice for each size.
The recall does not specify a remedy, so contact Smith & Nephew directly for further instructions.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-2331-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2331-2020 from Smith & Nephew. 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.
