Smith & Nephew recalls R3 Multi-Hole Hemispherical Stiktite Coated Shells with out of specification dimensions. Affected sizes and lot numbers listed. Consumers should contact for details.
A manufacturing error resulted in out of specification R3 Acetabular Shells
Smith & Nephew is recalling certain R3 Multi-Hole Hemispherical Stiktite Coated Shells due to a manufacturing error that caused the shells to be out of specification. This could lead to improper fit during orthopedic surgery, potentially causing complications for patients.
A manufacturing error resulted in the shells not meeting the required specifications. This could cause improper fit during hip replacement surgery, potentially leading to complications such as instability or improper joint alignment.
Orthopedic patients who have received the recalled R3 shells during surgery are most at risk. The affected items are specific sizes and lot numbers used in hip replacements.
Check the product size (48mm to 58mm) and lot number listed in the recall notice. The product is used in hip replacements and has specific reference numbers like 71338663 through 71338668.
Reach out to Smith & Nephew directly to confirm if your specific lot number and size are affected.
The affected sizes are 48mm to 58mm (reference numbers 71338663 through 71338668).
Check the product size and lot number against the list provided in the recall notice.
No immediate action is required for the shell itself, but you should contact Smith & Nephew to confirm if your specific lot number is affected.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-2335-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2335-2020 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.
