Biomet recalls 25mm shoulder screws labeled as 25mm but packaged as 40mm. This mismatch could cause improper implant fixation. Affected units include model 115395 with lot 077170.
Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
Biomet is recalling shoulder screws that were mistakenly labeled as 25mm but packaged as 4:00mm. Using the wrong size could lead to improper implant fixation and potential complications after surgery.
The screws were packaged as 25mm but labeled as 40mm. Using a longer screw than intended could cause improper implant fixation, potentially leading to complications after surgery.
Orthopedic surgeons and patients who received the Central Screw 6.5x25mm (model 115395) for shoulder replacements are affected. Those who have the screws from lot 077170 are most at risk.
Check for model number 115395 and lot number 077170 on the packaging. The screws are used for shoulder prostheses and are sterile.
Look for model number 115395 and lot number 077170 on the packaging.
Biomet found that a 40mm screw was packaged and labeled as a 25mm screw, which could cause improper implant fixation.
Check the model number and lot number on the packaging. If it matches 115395 and 077170, contact Biomet for guidance.
Yes, using the wrong length could lead to improper implant fixation and potential complications after surgery.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1131-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1131-2021 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.
