Globus Medical recalls specific ALTERA Spacer implants with possible stainless steel components instead of cobalt chromium molybdenum alloy. Affected lots may pose a risk of improper function or failure.
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 improper function or failure of the implant.
The implants may have been manufactured with stainless steel instead of the required cobalt chromium molybdenum alloy. This difference in material could cause the implant to function improperly or fail, potentially leading to complications.
Patients who received the recalled ALTERA Spacer implants from specific lots. Those with implants made from stainless steel instead of the specified alloy are at risk of improper function or failure.
Check the product label for the part number 1124.1135 and lot numbers BAX178PE, BAX236NE, BAX398UE, or BAX431SE.
Look for the part number 1124.1135 and lot numbers BAX178PE, BAX236NE, BAX398UE, or BAX431SE on the implant.
The implants may contain stainless steel instead of the specified cobalt chromium molybdenum alloy, which could cause improper function or failure.
Check the product label for part number 1124.1135 and lot numbers BAX178PE, BAX236NE, BAX398UE, or BAX431SE.
The recall does not specify a remedy, so contact Globus Medical for further instructions.
We’ve drafted a message you can send Globus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2864-2020 — Globus Medical Globus Medical Hello, I own a Globus Medical that is covered by recall Z-2864-2020 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.
