Globus Medical recalls ALTERA Spacer implants with potential stainless steel components instead of cobalt chromium molybdenum alloy. Affected lots may pose health risks.
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 contain stainless steel instead of the intended cobalt chromium molybdenum alloy. This could lead to health risks if the implants are used in the body.
The implants may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy. This difference in material could cause health issues if the implants are used in the body.
Patients who received the recalled ALTERA Spacer implants during surgery are likely affected. Those with the specific lot numbers listed in the recall are at risk.
Check the product label for the lot number or UDI number listed: BAX178LE, BAX178KE, BAX189PE, or BAX348EE. These specific lots are affected by the recall.
Look for the lot number or UDI number on the implant label to determine if it is affected.
The implants may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Affected lots include BAX178LE, BAX178KE, BAX189PE, and BAX348EE.
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-2860-2020 — Globus Medical Globus Medical Hello, I own a Globus Medical that is covered by recall Z-2860-2020 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.