Globus Medical recalls specific ALTERA Spacer implants with possible stainless steel components instead of cobalt chromium molybdenum alloy. Affected units have unique lot numbers. Contact for replacement.
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 certain ALTERA Spacer implants that may contain stainless steel instead of the specified cobalt chromium molybdenum alloy. This could lead to complications if the implant fails under stress. Affected units have specific lot numbers.
The implants may have been made with stainless steel instead of the intended cobalt chromium molybdenum alloy. This difference in material could cause the implant to fail under stress, potentially leading to complications during spinal fusion procedures.
Patients who received the recalled ALTERA Spacers during surgery are most at risk. The recall affects specific lot numbers of implants used in spinal procedures.
Check the lot number on the implant, which is listed as BAX108TE, BAX178ME, BAX208TE, BAX299NE, or BAX413CE/GE. These specific lot numbers correspond to the recalled units.
Reach out to Globus Medical directly to confirm if your implant is affected and get instructions for replacement.
The recall is due to specific lots of ALTERA Spacers potentially being manufactured with stainless steel instead of the specified cobalt chromium molybdenum alloy.
Check the lot number on your implant; affected units have specific lot numbers like BAX108TE, BAX178ME, BAX208TE, BAX299NE, or BAX413CE/GE.
The official recall does not specify a stop-use instruction; contact Globus Medical to determine if your implant is affected.
We’ve drafted a message you can send Globus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2863-2020 — Globus Medical Globus Medical Hello, I own a Globus Medical that is covered by recall Z-2863-2020 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.
