Encore Medical recalls Altivate Anatomic Glenoid Trial implants (size 42mm) due to potential design flaw that may cause improper fit during shoulder surgery. Affected units include 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 Glenoid Trial shoulder implants (size 42mm) because the design of the pegs may be too large compared to the implants, potentially causing improper fit during surgery. This could lead to complications for patients needing shoulder replacements.
The pegs at the base of the implants are designed to be larger than the actual implants, which could cause improper fit during shoulder surgery. This mismatch might lead to complications such as improper joint alignment or instability in the surgical repair.
Patients who received the specific Altivate Anatomic Glenoid Trial implants (size 42mm) with part numbers 804-07-380 to 804-07-540 during surgery are affected. Surgeons and medical facilities using these implants are most 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 or documentation. The product was used in shoulder surgeries for patients with pain and joint dysfunction.
Review the part numbers on the implant to confirm if it matches the recalled range (804-07-380 to 804-07-540).
The design of the pegs at the base of the implants is larger than the actual implants, which could cause improper fit during shoulder surgery.
The recall does not specify a remedy, so contact Encore Medical directly for guidance on next steps.
The recall indicates a potential for improper fit during surgery, which could lead to complications like joint instability or misalignment.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1257-2018 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-1257-2018 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.
