Biomet recalls specific fibula plates due to potential packaging failure causing infection risks during surgery. Affected items have item # 856204008 and lot # 913430. Contact for replacement or return.
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Biomet is recalling a specific type of fibula plate used in trauma surgery because its packaging might not seal properly, increasing infection risk during surgery. This could require additional surgery or longer procedures to find the correct implant.
The vacuum-sealed packaging may not stay closed on all sides, allowing bacteria to enter. This could lead to infections that require additional surgery to find and replace the affected implant.
Patients who received the specific fibula plate model with item # 856204008 and lot # 913430 are affected. Surgeons and medical staff using this product during procedures are at higher risk.
Check for item number 856204008 on the packaging and lot number 913430 on the label. The product comes in a vacuum-sealed nylon pouch inside a carton with patient record labels.
Look for item number 856204008 and lot number 913430 on the vacuum-sealed pouch and carton.
The packaging may not seal properly, increasing infection risk during surgery and potentially requiring additional procedures.
Check the item number and lot number on the packaging. If affected, contact Biomet for instructions.
Yes, the packaging failure could lead to infections requiring additional surgery.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0811-2022 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0811-2022 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.
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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.
