Biomet recalls specific lots of Phoenix interlocking screws for IM nail procedures due to potential packaging seal breaches that could compromise sterility. Affected items include item numbers 14-405040, 14-405042, 14-405044, 14-405070 with lot numbers 373200, 168810, 450100, 168540, 450090.
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 Phoenix interlocking screws used in medical procedures because the packaging might have been compromised, risking contamination. This could lead to infections or other complications if the device is used without proper sterility.
The packaging seal could be breached, leading to loss of sterility. If the device is not sterile, it could cause infections or other complications during medical procedures.
Patients undergoing fracture fixation procedures with these specific screws are at risk. Medical professionals using the recalled item numbers should check their lot numbers.
Check for item numbers 14-405040, 14-405042, 14-405044, or 14-405070. The affected lot numbers are 373200, 168810, 450100, 168540, and 450090.
Identify if your screws have item numbers 14-405040, 14-405042, 14-405044, or 14-405070.
Confirm if your screws have lot numbers 373200, 168810, 450100, 168540, or 450090.
The packaging seal might be breached, which could lead to loss of sterility and potential contamination of the device.
Check if your item numbers and lot numbers match the recalled items. If they do, contact Biomet for further instructions.
The recall is for potential contamination risk, not immediate injury. Serious injury is not mentioned in the official notice.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0625-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0625-2021 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.