Globus Medical recalls specific lots of ALTERA Spacer implants that may contain stainless steel instead of cobalt chromium molybdenum alloy. Affected units have unique part and lot numbers.
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 might have been made with stainless steel instead of the intended cobalt chromium molybdenum alloy. This could pose a risk of complications if the implant fails in the body.
The implants may contain stainless steel instead of the specified cobalt chromium molybdenum alloy. This difference in material could lead to potential complications if the implant fails in the body, though the risk is not immediately life-threatening.
Patients who received the recalled ALTERA Spacer implants during the specified time period are most at risk. The recall affects specific lots manufactured with unique part and lot numbers.
Check for the part number 1124.1235 and lot numbers starting with BAX103WE or BAX227VE. The recall applies to implants sold with specific serial numbers.
Review your implant's part number and lot numbers to see if they match the recalled specifications.
No, only specific lots with part number 1124.1235 and lot numbers starting with BAX103WE or BAX227VE are affected.
The recall does not specify a remedy, so check with your healthcare provider for guidance.
The recall states the implants may have different material, but it does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Globus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2871-2020 — Globus Medical Globus Medical Hello, I own a Globus Medical that is covered by recall Z-2871-2020 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.