Howmedica Knee Prosthesis Recall: Incorrect Implant Size Risk
Howmedica recalls knee prosthesis devices that may contain incorrect implant sizes. This affects revision total knee arthroplasty procedures. Consumers should check product lot codes.
Lower-risk recall
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/72135-howmedica-knee-prosthesis-recall-incorrect-implant-size-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72135-howmedica-knee-prosthesis-recall-incorrect-implant-size-risk · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1512-2018
Cite this page
“Howmedica Knee Prosthesis Recall: Incorrect Implant Size Risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72135-howmedica-knee-prosthesis-recall-incorrect-implant-size-risk. Based on FDA recall #Z-1512-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1512-2018%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Howmedica- Category
Medical device
What to do — step by step
Check Product Lot Code
Look for the lot code on the product box: ATV7IA for Catalog 5521-B-300 or ATY40A for Catalog 5521-B-400.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the recalled product?
Check the product box for the specific lot codes mentioned. If you have the recalled lot codes, contact Howmedica for further instructions.
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Where this comes from
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.
- Official source: FDA Recall #Z-1512-2018 (January 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1512-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.