Globus Medical recalls specific ALTERA Spacer implants with possible stainless steel components instead of cobalt chromium molybdenum alloy. Affected units have unique lot numbers and part 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 may contain stainless steel instead of the required cobalt chromium molybdenum alloy. This could lead to complications if the implant fails under stress during medical procedures.
The implants may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy. This difference in material could cause the implant to fail under stress during medical procedures, potentially leading to complications.
Patients who received the recalled ALTERA Spacer implants during surgery are most at risk. The recall applies to specific lot numbers and part numbers used in certain surgical procedures.
Check for the part number 1124.1115 and lot numbers like BAX159RE, BAX178JE, BAX208RE, BAX229UE, BAX250BE, BAX308BE, BAX347YE, or BAX351KE on the implant packaging or documentation.
Look for the part number 1124.1115 and specific lot numbers listed in the recall notice.
The recall is because specific lots of ALTERA Spacer implants may have been manufactured with stainless steel instead of the required cobalt chromium molybdenum alloy.
Check for the part number 1124.1115 and lot numbers like BAX159RE, BAX178JE, BAX208RE, BAX229UE, BAX250BE, BAX308BE, BAX347YE, or BAX351KE on the implant packaging or documentation.
The recall notice does not specify a remedy or action for affected implants.
We’ve drafted a message you can send Globus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2861-2020 — Globus Medical Globus Medical Hello, I own a Globus Medical that is covered by recall Z-2861-2020 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.
