Biomet recalls specific shoulder implant models due to potential elevated endotoxin levels exceeding safety limits. Affected units include Hybrid Glenoid Glenoid Base and Comprehensive Reverse Shoulder Humeral models with listed lot numbers.
Potential presence of elevated endotoxin levels that exceed the specification limit
Biomet is recalling two specific shoulder implant models because they may contain endotoxin levels that exceed safety standards. This could pose a risk to patients during surgery or recovery.
The implants may have elevated endotoxin levels that exceed specified safety limits. Endotoxins are natural components of bacterial cell walls that can cause inflammation or infection if present in high concentrations during medical procedures.
Patients who received one of the recalled shoulder implants during surgery between the listed lot numbers. Surgeons and medical facilities using these implants are also affected.
Check the product label for the specific item numbers: 113954 (Hybrid Glenoid Glenoid Base) or XL-115366/XL-115364 (Comprehensive Reverse Shoulder Humeral). The lot numbers are listed in the UDI codes provided in the recall notice.
Look for the item numbers 113954 or XL-115366/XL-115364 on the implant packaging or label.
The recall is due to potential elevated endotoxin levels in the implants that exceed safety specifications, which could increase the risk of infection or inflammation during surgery.
Check the product label for the specific item numbers and lot numbers listed in the recall notice. If you have the recalled items, contact Biomet directly for further instructions.
The recall indicates a potential risk of elevated endotoxin levels that could cause inflammation or infection, but the hazard level is considered low risk as the remedy does not require immediate discontinuation.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2144-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2144-2020 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.
