Howmedica recalls knee prosthesis devices that may contain incorrect implant sizes. This affects revision total knee arthroplasty procedures. Consumers should check product lot codes.
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Howmedica is recalling knee prosthesis devices used in revision total knee surgeries because some units may have the wrong implant size labeled on the box. This could lead to improper surgical fitting and complications during the procedure.
The recalled knee prosthesis devices may contain an implant that is the incorrect size as labeled on the product box. This mismatch could lead to improper surgical fitting during revision knee replacement procedures, potentially causing complications.
Patients who have received revision total knee arthroplasty using the recalled knee prosthesis devices (Catalog 5521-B-300, lot ATV7IA; Catalog 5521-B-400, lot ATY40A) are affected. Surgeons and patients using these specific models during revision procedures are at risk.
Check the product box for Catalog numbers 5521-B-300 (lot ATV7IA) or 5521-B-400 (lot ATY40A). These devices are used in revision total knee arthroplasty procedures.
Look for the lot code on the product box: ATV7IA for Catalog 5521-B-300 or ATY40A for Catalog 5521-B-400.
The recall indicates a potential risk of incorrect implant size, but the devices are not unsafe if they are not the recalled lot codes.
Check the product box for the specific lot codes mentioned. If you have the recalled lot codes, contact Howmedica for further instructions.
Verify by checking the product box for Catalog 5521-B-300 (lot ATV7IA) or 5521-B-400 (lot ATY40A).
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-1512-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-1512-2018 from Howmedica. 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.