Biomet recalls specific lots of Comprehensive Reverse Shoulder System implants due to potential breach in sterile packaging seals, risking loss of sterility. Affected patients should contact Biomet for details.
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Biomet is recalling specific lots of Comprehensive Reverse Shoulder System implants because some may have a breach in the sterile packaging seal. This could lead to loss of sterility, which is a serious risk during surgery.
The sterile packaging seal may be compromised, leading to loss of sterility. This could cause infection or complications during surgery if the device is used without proper sterility.
Patients who received the recalled implants (item numbers 115394-180562) from Biomet. Those with shoulder replacements requiring the specific implants are most at risk.
Check if your implant has item numbers listed in the recall (e.g., 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553). The recall covers specific lots of the Comprehensive Reverse Shoulder System.
Identify if your implant has item numbers listed in the recall (e.g., 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553).
Reach out to Biomet directly for instructions on next steps if your implant is affected.
Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, and other specific lots listed in the recall.
The recall is due to potential breaches in the sterile packaging seal, which could lead to loss of sterility and infection risks during surgery.
No action is needed if your implant's item number is not on the list of affected lots.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0619-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0619-2021 from Biomet. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
