Smith & Nephew recalls R3 Multi-Hole HA Coated Hemispherical Stiktitite Shell implants due to manufacturing errors causing out-of-specification shells. Affected sizes and lot numbers listed.
A manufacturing error resulted in out of specification R3 Acetabular Shells
Smith & Nephew is recalling certain R3 Multi-Hole HA Coated Hemispherical Stiktitite Shell implants because of a manufacturing error that produced shells outside the specified dimensions. This could affect orthopedic implants used in joint replacements.
The recall is due to a manufacturing error that resulted in shells that do not meet the required specifications. This could lead to improper fit or function during joint replacement surgery, potentially causing complications for patients.
Orthopedic patients who received the recalled R3 Multi-Hole HA Coated Hemispherical Stiktitite Shell implants during the specified manufacturing periods. Surgeons and medical facilities using these implants are also at risk.
Check if your implant is labeled with a size (48mm to 64mm) and the specific product number (71338733-71338741). Also, verify the lot numbers listed for each size.
Identify your implant's size and product number from the list provided in the recall notice.
The affected sizes are 48mm, 50mm, 52mm, 54mm, 56mm, 58mm, 62mm, and 64mm.
The affected product numbers are 71338733 through 71338741.
Lot numbers vary by size: 19DM28110, 19DM28106, 19DM28106A for 71338733; 19DM28114 for 71338734; and so on as listed in the recall notice.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-2336-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2336-2020 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.
