Smith & Nephew recalls R3 acetabular shells with out-of-specification manufacturing due to a production error. Affected sizes and lots listed in the recall notice.
A manufacturing error resulted in out of specification R3 Acetabular Shells
Smith & Nephew is recalling certain R3 acetabular shells that were manufactured with a production error causing them to be out of specification. These implants are used in hip replacements and may not function properly, leading to potential complications.
The recall is due to a manufacturing error that resulted in the shells not meeting specifications. This could lead to improper function during hip replacement surgery, potentially causing complications or failure of the implant.
Orthopedic patients who received the recalled R3 acetabular shells during hip replacement surgery. Patients with the specific sizes and lot numbers listed in the recall are most at risk.
Check the product size (42mm to 68mm) and lot number on the shell. The recall includes specific product numbers and lot numbers listed in the notice.
Identify the size (42mm to 68mm) and lot number from the product label to determine if it's affected.
Smith & Nephew R3 Three-Hole HA Coated Hemispherical Stiksite Coated Shell, used in hip replacements.
Affected sizes include 42mm to 68mm with specific lot numbers listed in the recall notice.
If you have the affected product, check the size and lot number to see if it's listed. Contact Smith & Nephew 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-2334-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2334-2020 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.
