Encore Medical recalls Altivate Anatomic Shoulder Implants with potential design flaw causing mismatched pegs. Affected models include size 38mm with part numbers 804-07-380 to 804-07-540. Consumers should check serial numbers for affected units.
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 specific shoulder implants due to a design issue where the pegs may not fit properly with the implants during surgery. This could lead to improper joint function or complications if the implants are used without the correct fit.
The design of the radius at the base of the pegs is larger than the implants during surgery. This mismatch could cause improper alignment or movement of the joint, potentially leading to complications during the procedure.
Patients who received the Altivate Anatomic Shoulder System with the specified part numbers (804-07-380 to 804-07-540) are affected. Surgeons and medical facilities using these implants are most at risk.
Check the product's part numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, or 804-07-540. The affected implants are part of the Altivate Anatomic Shoulder System, size 38mm.
Review the part numbers on the implant to confirm if it is one of the affected models (804-07-380 to 804-07-540).
The design of the radius at the base of the pegs is larger than the implants during surgery, which could cause improper alignment.
Part numbers 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540 are affected.
The recall does not require stopping use; it is a design issue that may need correction during surgery.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1256-2018 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-1256-2018 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.
