Howmedica Osteonics recalls certain LFIT Anatomic CoCr Femoral Heads (model 6260-9-036) manufactured before March 4, 2011 due to reported femoral head/hip stem disassociation. Affected units include specific lot numbers listed in the recall.
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 (model 6260-9-036) manufactured before March 4, 2011 because customers have reported femoral head/hip stem disassociation. This could lead to joint instability or pain if not addressed.
The femoral head/hip stem can become disassociated (separated) in certain sizes of these implants, which may cause joint instability or pain. This issue has been reported by customers but does not typically cause serious injury in normal use.
Patients who have received a femoral head implant from this specific model (6260-9-036) manufactured before March 4, 2011 are most at risk. The recall includes specific lot numbers listed in the notice.
Check if your implant is labeled as LFIT Anatomic CoCr Femoral Heads with model number 6260-9-036. The recall covers specific lot numbers listed in the notice, all manufactured before March 4, 2011.
Identify if your implant is labeled as LFIT Anatomic CoCr Femoral Heads with model number 6260-9-036.
Confirm if your implant's lot number is in the list provided in the recall notice (all manufactured before March 4, 2011).
The recall does not specify a replacement requirement. Affected units should be checked against the list of lot numbers provided in the notice.
Contact Howmedica Osteonics directly to discuss your specific implant and possible next steps.
The recall reports disassociation but does not indicate a risk of serious injury in normal use. Affected units may experience joint instability or pain.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-2292-2018 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-2292-2018 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.