Smith & Nephew recalls certain R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shell implants due to manufacturing errors causing out of specification shells.
A manufacturing error resulted in out of specification R3 Acetabular Shells
Smith & Nephew is recalling specific sizes of R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shell implants because they were manufactured with incorrect specifications. This could lead to improper joint fitting and potential complications during hip replacement surgery.
The implants were manufactured with out of specification dimensions, which could result in improper fit during hip replacement surgery. This may cause joint instability or complications requiring additional surgical intervention.
Orthopedic surgeons and patients who have received the recalled implant sizes (42mm to 64mm) from Smith & Nephew. Patients with hip replacements using these specific sizes are most at risk.
Check your implant's size (42mm to 64mm) and product number (71332242 to 71332264). Look for specific lot numbers listed in the recall notice for each size.
Identify your implant size (42mm to 64mm) and product number (71332242 to 71332264) to determine if it is affected.
The recall is due to a manufacturing error that resulted in out of specification R3 Acetabular Shells.
Check your implant's size and product number against the list provided in the recall notice to see if it is affected.
The recall indicates potential improper fit during hip replacement surgery, but the risk is low and does not involve immediate danger.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-2332-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2332-2020 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.
