Biomet recalls a specific orthopedic plate for temporary fracture fixation due to incomplete design history files before distribution. This affects certain surgical implants used in bone repair procedures.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a specific type of proximal humerus plate used in bone fracture repairs because it was distributed without completing required design history files. This means the product may not meet safety standards before being used in surgeries.
The recall occurs because the plate was distributed without completing required design history files. This means the product may not meet safety standards before being used in surgeries, potentially leading to complications during bone repair procedures.
Surgical patients who received this specific plate during procedures between 2017 and 2020 are likely affected. Surgeons using this model for temporary bone fixation are at risk if they have not completed the necessary design checks.
Check for the product name 'A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM' with item number 110030407. This plate was used in surgeries between 2017 and 2020.
Identify if you have the specific plate model with item number 110030407 used in surgeries between 2017 and 2020.
The plate was distributed without completing required design history files before being used in surgeries.
The official recall notice does not mention any remedy or corrective action.
The official recall notice does not specify a contact for assistance.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2322-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2322-2020 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.
