Biomet Knee Products Recall: Elevated Endotoxin Risk

Take action

Contact the company & request your remedy

Recalling firmBiomet, Inc.56 E Bell Dr, N/A · Warsaw, IN 46582-6989

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Biomet is recalling two specific knee implant models (Regenerex Series-A Patella 3 Peg, 31mm and 37mm) because they may contain endotoxin levels above safe limits. This could pose a risk to patients using these implants.

Why it’s dangerous

The implants may contain elevated endotoxin levels that exceed the manufacturer's safety specifications. Endotoxins are substances that can cause infections or inflammatory responses in the body, especially in medical implants.

Who’s affected

Patients who have received the recalled knee implants with specific lot numbers (UDI numbers starting with 561760 or 091090) are affected. Those with these implants are most at risk.

How to tell if you have this one

Check your implant's UDI number for the specific lot numbers: 561760 (01)00880304554412(17)211229(10)561760 or 091090 (01)00880304506084(17)211214(10)091090. These models are Regenerex Series-A Patella 3 Peg with 31mm or 37mm sizes.

Brand
Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Your Implant UDI
Look for the UDI number on your implant to determine if it matches the recalled lot numbers: 561760 or 091090.

✎ GovInfoNow

Questions people ask

What is the specific hazard with these implants?

The implants may contain elevated endotoxin levels that exceed the manufacturer's safety specifications.

How can I tell if my implant is affected?

Check your implant's UDI number for the specific lot numbers: 561760 (01)00880304554412(17)211229(10)561760 or 091090 (01)00880304506084(17)211214(10)091090.

What should I do if my implant is affected?

The recall does not specify a remedy, so contact Biomet directly for further instructions.

Take action

Contact Biomet

We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2146-2020 — Biomet Biomet

Hello,

I own a Biomet that is covered by recall Z-2146-2020 from Biomet.

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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-2146-2020 (April 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2146-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.

Biomet, Inc. recalls Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product

Lower-risk recall