Encore Medical recalls Altivate Anatomic Shoulder Implants (size 54mm) due to a design flaw that may cause improper fit during surgery. Affected units have specific part numbers and serial numbers.
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
Encore Medical is recalling certain Altivate Anatomic Shoulder Implants (size 54mm) because the design of the pegs may not fit properly with the patient's bone. This could lead to improper joint replacement during surgery, potentially causing complications.
The pegs at the base of the implant have a larger radius than the implants themselves, which could cause improper alignment during surgery. This mismatch might lead to incorrect joint placement, increasing the risk of complications like instability or improper healing.
Patients who received the Altivate Anatomic Shoulder Implant (size 54mm) with part numbers 804-07-380 to 804-07-540 are affected. Surgeons and medical facilities using these implants during procedures are at risk.
Check for part numbers 804-07-380, 804-07-420, 804-07-460, 804-07-500, or 804-07-540 on the implant packaging. The product is sold as the Altivate Anatomic Shoulder System for patients needing shoulder joint replacement.
Review the part numbers on the implant packaging to confirm if it is affected (804-07-380 to 804-07-540).
The design of the pegs at the base of the implant has a larger radius than the implants themselves, which could cause improper alignment during surgery.
Part numbers 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540.
The recall does not specify a remedy, so there is no action required beyond checking if your implant is 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-1260-2018 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-1260-2018 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.
