Biomet recalls Sterile Trac System Thinflap 24 MM Burr Hole Plates (Lot 078390) due to potential packaging seal breaches that could compromise sterility during cranial bone fixation procedures.
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Biomet is recalling a specific lot of Sterile Trac System Thinflap 24 MM Burr Hole Plates used in cranial bone surgery. The recall is because some units may have a packaging seal breach that could lead to loss of sterility, potentially causing infections during surgery.
The packaging seal on some units may be breached, which could allow contamination of the sterile device. This loss of sterility during surgery could lead to infections in patients.
Surgical teams using the Sterile Trac System Thinflap 24 MM Burr Hole Plate (Lot 078390) for cranial bone fixation procedures are affected. Patients undergoing surgery with this specific product are at risk of infection if the packaging seal was compromised.
Check for the product name 'Sterile Trac System Thinflap 24 MM Burr Hole Plate' with item number SP-STA-1021-12. The affected lot number is 078390.
Look for the lot number 078390 on the packaging to determine if your item is affected.
The recall only applies to specific lots (078390). Other lots may be safe, but the manufacturer recommends checking the lot number.
Check the lot number on the packaging. If it's 078390, contact Biomet for further instructions.
The recall is due to potential loss of sterility, which could lead to infections. Serious injury is not directly stated as a risk in this recall.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0629-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0629-2021 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.
