Biomet recalls specific lots of M/H Modular Stem devices used in limb salvage procedures due to potential packaging seal breaches that could compromise sterility.
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 M/H Modular Stem devices used in limb salvage procedures because some packaging seals might be broken, risking contamination. This could lead to infections or other complications during surgery.
The packaging seal may be breached, allowing contaminants to enter the sterile device. This could lead to infections or other complications during surgery if the device is used without proper sterility.
Surgical teams using the recalled M/H Modular Stem devices for limb salvage procedures. Patients undergoing these surgeries are at risk if the device is contaminated.
Check the lot number on the device packaging. The recalled lot is 832990. The product is used in limb salvage procedures and has item number 13-1047:104756.
Look for the lot number 832990 on the packaging to identify if the device is recalled.
The recalled lot number is 832990.
The M/H Modular Stem is intended for use in limb salvage procedures.
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-0622-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0622-2021 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.