Signature Orthopedics recalls ceramic femoral heads (model 111-152-621) due to mislabeling causing surgical delays. Affected products may not include the intended surgical component, leading to replacement delays.
This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved.
Signature Orthopedics is recalling ceramic femoral heads (model 111-152-621) because they were mislabeled. This means the product might not match what's needed for surgery, causing delays in getting the correct replacement part.
The product was mislabeled, so the packaged component's size doesn't match the label. This means the surgical team might not have the correct part for the procedure, leading to delays in replacing the hip joint.
Surgeons and hospitals using the Signature ceramic femoral heads (model 111-152-621) for hip replacements are affected. Patients undergoing hip surgery with this specific model are at risk of delayed procedures.
Check for the model number 111-152-621 on the packaging. The product was manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta) and sold with a specific lot number (78560).
Look for the model number 111-152-621 on the packaging to confirm if the product is affected.
The product was mislabeled, causing the packaged component's size to not match the label. This may result in the surgical team not having the correct part for the procedure, leading to delays.
Check the model number on the packaging. If it matches 111-152-621, contact Signature Orthopedics for guidance on next steps.
The recall is for mislabeling that could cause surgical delays, not a direct injury risk. The hazard does not involve physical harm to users.
We’ve drafted a message you can send Signature Orthopedics to request your refund or repair — edit it as you like.
Subject: Recall Z-0920-2018 — Signature Orthopedics Signature Orthopedics Hello, I own a Signature Orthopedics that is covered by recall Z-0920-2018 from Signature Orthopedics. 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.
