Encore Medical recalls AltiVate Anatomic Shoulder System parts due to humeral stem failing to mate with broach handles, potentially causing procedure delays or revision surgery.
Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.
Encore Medical is recalling specific parts of their AltiVate Anatomic Shoulder System because the humeral stem may not properly connect with the broach handles. This could lead to surgery delays or the need for additional procedures.
The humeral stem in the shoulder device may fail to properly attach to the broach handles during surgery. This could cause the procedure to be delayed or require revision surgery to fix the issue.
Orthopedic surgeons and patients using the AltiVate Anatomic Shoulder System with the listed part numbers are affected. Surgeons using the recalled parts are most at risk of procedure delays.
Check if your AltiVate Anatomic Shoulder System includes part numbers 520-08-00 (Rev. C), 520-10-000, 520-12-000, 520-14-000, or 520-16-000 with specific lot numbers listed in the recall notice.
Identify if your AltiVate Anatomic Shoulder System includes part numbers 520-08-00 (Rev. C), 520-10-000, 520-12-000, 520-14-000, or 520-16-000 with the listed lot numbers.
The humeral stem may fail to mate with the broach handles, which could cause surgery delays or revision procedures.
Part numbers 520-08-00 (Rev. C), 520-10-000, 520-12-000, 520-14-000, and 520-16-000 with specific lot numbers listed in the recall notice.
The recall does not specify a remedy, so no action is required beyond checking if your parts are affected.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2331-2021 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-2331-2021 from Encore 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.
