Medacta recalls specific shoulder implant models (ref 04.01.0023-04.01.0055) due to potential screw insertion issues. Affected users should check their implant lot numbers.
Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.
Medacta recalls certain shoulder implants (model ref 04.01.0023 through 04.01.0055) because the implant's size might prevent proper screw locking. This could lead to improper joint fixation during surgery.
The implant's dimensional condition may limit the screw's ability to lock securely to the humerus bone. This could result in improper joint fixation during surgery, potentially requiring additional procedures.
Patients who received the specific Medacta Shoulder System Humeral Anatomical Metaphysis implants with lot numbers 04.01.0023 to 04.01.0055 are affected. Surgeons and medical facilities using these implants are at risk during procedures.
Check your implant's lot number, which is listed as 04.01.0023 through 04.01.0055. The product is part of the Medacta Shoulder System Humeral Anatomical Metaphysis.
Identify your implant's lot number, which should be between 04.01.0023 and 04.01.0055.
The affected models are Medacta Shoulder System Humeral Anatomical Metaphysis with lot numbers 04.01.0023 through 04.01.0055.
The recall is due to a dimensional condition that may prevent the screw from locking properly to the humerus bone during surgery.
If your implant's lot number is within the affected range, you should check with your surgeon about potential next steps.
We’ve drafted a message you can send Medacta to request your refund or repair — edit it as you like.
Subject: Recall Z-0775-2020 — Medacta Medacta Hello, I own a Medacta that is covered by recall Z-0775-2020 from Medacta. 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.