Zimmer Biomet recalls specific segmental system proximal femoral components for possible debris in the hole during machining, which may not have been fully cleaned. This affects certain surgical implants used in complex bone repair cases.
There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
Zimmer Biomet is recalling a specific type of surgical implant for complex bone repair cases. The recall is due to a potential debris issue in the device's hole that may not have been properly cleaned during manufacturing, which could lead to complications during surgery.
During manufacturing, debris may remain in the hole on the superior lateral aspect of the device due to machining. This debris could potentially cause complications during surgery if not properly cleaned, but the hazard is not described as causing serious injury in normal use.
Surgical patients who received the specific model number 00-5850-030-38 segmental system proximal femoral component during procedures for severe bone loss. Patients who have this implant are most at risk.
Check if your implant has the model number 00-5850-030-38. This component is used in complex salvage cases for severe bone loss due to disease, trauma, or revision.
Verify if your implant has the model number 00-5850-030-38.
No, this implant is specifically used for complex salvage cases where patients have severe bone loss due to disease, trauma, or revision.
Check if your implant has the model number 00-5850-030-38. If so, contact Zimmer Biomet for further instructions.
The recall states there is a potential for debris that may not have been fully cleaned, but it does not describe a risk of serious injury in normal use.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1381-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1381-2018 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.