Zimmer Biomet recalls StageOne Hip cement spacer molds 431207 and 431209 due to potential mixing of 43mm and 51mm molds. These sterile medical devices could cause incorrect joint fitting if used improperly.
There is a potential for comingling of the 43MM and 51 MM molds
Zimmer Biomet is recalling two specific models of hip cement spacer molds (431207 and 431209) because there's a risk of mixing up the 43mm and 51mm sizes. This could lead to improper joint fitting during hip surgery if the wrong mold size is used.
The molds are designed to be filled with bone cement for hip surgery. If the 43mm and 51mm molds are mixed up during use, the wrong size could be implanted, potentially causing improper joint alignment.
Patients undergoing hip replacement surgery who use these specific mold models are at risk. Surgeons and medical staff handling the recalled molds may also be affected.
Check for the model numbers 431207 or 431209 on the mold packaging. These molds were sold with specific lot numbers: 705550 for 431207, and 705570 or 705580 for 431209.
Look for model numbers 431207 or 431209 on the mold packaging to confirm if it's recalled.
The recall is due to a potential mix-up between 43mm and 51mm molds, which could lead to incorrect joint fitting during hip surgery.
Check the model number and lot number on the packaging. If it's 431207 with lot 705550 or 431209 with lot 705570 or 705580, contact Zimmer Biomet for guidance.
No, these molds are designed to be used safely with proper procedures. The risk only exists if the wrong size is used due to mixing.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0399-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0399-2019 from Zimmer 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.
