Biomet recalls specific lots of shoulder surgery implants due to potential packaging seal breaches that could compromise sterility during 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 certain lots of shoulder surgery implants because the packaging might have been compromised, risking contamination during surgery. This could lead to infections or other complications for patients receiving the procedure.
The packaging seal may have been breached, which could allow contamination of the sterile surgical instruments. If the instruments are not sterile, they could introduce infections into the patient's body during surgery.
Surgical patients who received the specific lot numbers of the Comprehensive Total Shoulder System from Biomet. Surgeons using these implants during procedures are most at risk.
Check the lot numbers on the packaging: 253970, 279180, 417710, or 499280. These are the specific lots of the Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System that are affected.
Identify the lot numbers on the packaging to see if they match the affected lots: 253970, 279180, 417710, or 499280.
The packaging seal may have been breached, which could lead to loss of sterility of the surgical instruments.
Check the lot numbers on the packaging to see if they match the affected lots: 253970, 279180, 417710, or 499280.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0620-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0620-2021 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.