Globus Medical recalls ALTERA Spacer implants with potential stainless steel components instead of cobalt chromium alloy. Affected lots may pose health risks if used in medical procedures.
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Globus Medical is recalling specific lots of ALTERA Spacer implants that may contain stainless steel instead of the intended cobalt chromium molybdenum alloy. This could lead to health risks during medical procedures if the implants are used.
The implants might have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy. This difference in material could cause adverse reactions or complications during medical procedures.
Patients who received the recalled ALTERA Spacer implants during surgery are most at risk. Medical professionals using these implants in procedures may also be affected.
Check for the part number 1124.1013 and lot numbers BAX104GE, BAX156GE, BAX156HE, BAX195WE, or BAX361LE on the implant packaging.
Review the part number and lot numbers on the implant packaging to confirm if it is affected.
The implants may contain stainless steel instead of the specified cobalt chromium molybdenum alloy, which could lead to health risks during medical procedures.
Check the part number 1124.1013 and lot numbers BAX104GE, BAX156GE, BAX156HE, BAX195WE, or BAX361LE on the implant packaging.
The recall record does not specify a remedy, so contact Globus Medical directly for guidance.
We’ve drafted a message you can send Globus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2853-2020 — Globus Medical Globus Medical Hello, I own a Globus Medical that is covered by recall Z-2853-2020 from Globus Medical. 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.