Smith & Nephew recalls R3 Three Hole Hemispherical Stiktitite Coated Shell implants due to manufacturing error causing out of specification shells. Affected sizes and lot numbers listed in the recall.
A manufacturing error resulted in out of specification R3 Acetabular Shells
Smith & Nephew is recalling R3 Three Hole Hemispherical Stiktitite Coated Shell orthopedic implants that were manufactured with out of specification shells. This recall affects specific sizes and lot numbers that were produced with a manufacturing error.
The recall is due to a manufacturing error that resulted in the shells being out of specification. This could potentially affect the fit and function of the implants during surgery, but the exact risk to patients is not specified in the recall notice.
Orthopedic patients who own or use the recalled R3 Three Hole Hemispherical Stiktitite Coated Shell implants. The most at-risk individuals are those who have the specific sizes and lot numbers listed in the recall.
Check if your implant is one of the sizes listed (40mm to 60mm) and matches the specific lot numbers provided in the recall notice. The product is an orthopedic implant component.
Identify your implant's size (40mm to 60mm) and lot number to see if it matches the affected items listed in the recall.
Smith & Nephew is recalling R3 Three Hole Hemispherical Stiktitite Coated Shell orthopedic implants that were manufactured with out of specification shells due to a manufacturing error.
Check if your implant's size (40mm to 60mm) and lot number match the specific numbers listed in the recall notice.
The recall notice does not specify a remedy, so you should 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-2333-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2333-2020 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.