Encore Medical recalls Altivate Anatomic Shoulder Implants with a design flaw that may cause improper fit during surgery. Affected models include size 46mm with part numbers 804-07-380 to 804-07-540. No specific remedy is stated in the recall notice.
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 due to a design flaw that may cause improper fit during surgery. This could lead to complications if the implant doesn't align correctly with the patient's anatomy.
The design of the radius at the base of the pegs is larger on the trails than on the implants. This mismatch could cause improper alignment during surgery, potentially leading to complications like incorrect joint positioning or instability.
Patients who received the recalled Altivate Anatomic shoulder implants (size 46mm, part numbers 804-07-380 to 804-07-540) are affected. Surgeons and medical facilities using these implants are at risk of complications during procedures.
Check for the product name 'Altivate Anatomic' with size 46mm and part numbers 804-07-380 to 804-07-540. The recall covers all serial numbers of these specific implants.
Identify if your implant has the part numbers 804-07-380 to 804-07-540 and size 46mm.
The recall is due to a design flaw where the radius at the base of the pegs is larger on the trails than on the implants, which could cause improper fit during surgery.
The recall notice does not specify a remedy, so contact Encore Medical directly for guidance.
Yes, part numbers 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540 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-1258-2018 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-1258-2018 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.
