Encore Medical recalls Altivate Anatomic Shoulder Implants (size 50mm) due to a design flaw where pegs may not align properly with implants during surgery, potentially causing complications. Affected units include specific part 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 50mm) because the pegs at the base of the implants are designed to be larger than the implants themselves. This could cause misalignment during surgery, leading to potential complications for patients.
The pegs at the base of the implants are designed to be larger than the implants themselves. This mismatch could cause the pegs to not align properly with the implants during surgery, potentially leading to complications such as improper joint function or additional surgical interventions.
Patients who have received the specific Altivate Anatomic shoulder implants (size 50mm) with part numbers 804-07-380 to 804-07-540 are affected. Surgeons and medical facilities using these implants during procedures are at the highest risk.
Check if your implant has part numbers 804-07-380, 804-07-420, 804-07-460, 804-07-500, or 804-07-540. The product is used in shoulder replacement surgeries and is labeled as the Altivate Anatomic Shoulder System.
Identify the part numbers on your implant to confirm if it is affected (804-07-380 to 804-07-540).
The pegs at the base of the implants are designed to be larger than the implants themselves, which could cause misalignment during surgery.
Check if your implant has part numbers 804-07-380, 804-07-420, 804-07-460, 804-07-500, or 804-07-540.
The recall record does not specify a remedy, so contact Encore Medical directly for guidance.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1259-2018 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-1259-2018 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.
