Biomet recalls specific lots of OSS Polyethylene Tibial Bushing for potential loss of sterility due to packaging seal breaches. Affected items may not be safe for limb salvage 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 specific lots of OSS Polyethylene Tib:ibial bushings used in limb salvage procedures because some packaging seals may be broken, risking loss of sterility. This could lead to infections or other complications during surgery.
The packaging seal may be breached, leading to loss of sterility. This could allow contaminants to enter the device, increasing infection risk during surgery.
Healthcare professionals using these bushings for limb salvage procedures. Patients undergoing surgery with these devices are at risk if the packaging seal is compromised.
Check the lot numbers: 059680, 542010, or 542020 on the packaging. These are specific lots of the OSS Polyethylene Tibial Bushing (item 150476) used in limb salvage procedures.
Look for lot numbers 059680, 542010, or 542020 on the device packaging.
OSS Polyethylene Tibial Bushing (item 150476) used in limb salvage procedures.
Lots 059680, 542010, and 542020.
The recall record does not specify a remedy.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0623-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0623-2021 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.
