Zimmer Biomet recalls Humeral Stem 55mm (Size 13) due to incorrect lot numbers and size differences that could lead to improper implantation. Affected patients should contact the manufacturer for guidance.
Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.
Zimmer Biomet is recalling Humeral Stem 55mm (Size 13) implants because they were mixed during manufacturing and have incorrect lot numbers. This could cause improper fitting if used in surgery, potentially leading to complications.
The stems were commingled during manufacturing, resulting in incorrect lot numbers and a 1.1-inch size difference between the two stem sizes. This mismatch could lead to improper implantation if the wrong size is used during surgery.
Patients who received this specific humeral stem implant for shoulder surgery are affected. Surgeons and medical staff using the product during procedures are at risk if they use the incorrect implant.
Check the box label for the product name and size. The affected stems have a label that does not match the contents inside the box.
Reach out to Zimmer Biomet directly for guidance on whether the implant is affected and next steps.
The stems were commingled during manufacturing, resulting in incorrect lot numbers and a 1.1-inch size difference between the two stem sizes.
Check the box label for the product name and size. The affected stems have a label that does not match the contents inside the box.
Contact Zimmer Biomet directly for guidance on whether the implant is affected and next steps.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0980-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0980-2018 from Zimmer 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.
