Howmedica Osteonics recalls LFIT Anatomic CoCr Femoral Heads (Catalog No. 6260-9-136) manufactured prior to March 4, 2011 due to higher than expected complaints of femoral head/hip stem disassociation.
The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
Howmedica Osteonics is recalling certain LFIT Anatomic CoCr Femoral Heads (Catalog No. 6260-9-136) made before March 4, 2011 because they've received more complaints about the femoral head and hip stem separating from each other. This could lead to serious complications during hip replacement surgery.
The recalled femoral heads have a higher than expected rate of disassociation between the femoral head and hip stem. This separation can cause the implant to become unstable, potentially leading to pain, additional surgery, or other complications during hip replacement procedures.
Patients who have received these specific femoral heads in hip replacement surgeries are most at risk. The recall applies to implants made before March 4, 2011.
Check if your hip replacement implant has the catalog number 6260-9-136 and was manufactured before March 4, 2011. The specific lots listed in the recall notice (many numbers) indicate which batches were affected.
Identify if your hip replacement implant has the catalog number 6260-9-136 and was manufactured before March 4, 2011.
Reach out to your surgeon or the manufacturer to discuss whether your implant is affected and what steps to take next.
Howmedica Osteonics has received a higher than expected number of complaints about femoral head/hip stem disassociation for these specific implants made before March 4, 2011.
The recall does not require immediate replacement. Patients should contact their surgeon to determine if their implant is affected and what action is needed.
The recalled implants have catalog number 6260-9-136.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-2295-2018 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-2295-2018 from Howmedica Osteonics. 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.
