Wright Medical recalls EVOLVE Proline Stem implants with incorrect sizes in packaging. Affected lots contain mismatched stem sizes that could lead to improper fitting during surgery.
The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.
Wright Medical is recalling certain EVOLVE Proline Stem implants because the package labels don't match the actual device size. This mismatch could cause improper surgical fitting if used without verification.
The package labels indicate one stem size, but the actual device contains a different size. For example, a package labeled for 9.5mm contains a 7.5mm stem. This mismatch could lead to improper surgical fitting if the wrong size is used.
Orthopedic surgeons and hospitals that purchased the affected lots (1704255) of EVOLVE Proline Stem implants. Patients are not directly affected since the recall is for surgical implants.
Check the lot number on the packaging (1704255) for the affected EVOLVE Proline Stem implants. The product includes a specific reference code (REF 496S275) and size markers (+4, 9.5mm).
Verify the product's size and lot number against the official recall information to confirm if it's affected.
The package labels do not match the actual device size in the affected lots, which could lead to improper surgical fitting.
For example, a package labeled for 9.5mm contains a 7.5mm stem, and vice versa.
Check the lot number on the packaging (1704255) for the affected EVOLVE Proline Stem implants with reference code REF 496S275.
We’ve drafted a message you can send Wright Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0006-2023 — Wright Medical Wright Medical Hello, I own a Wright Medical that is covered by recall Z-0006-2023 from Wright 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.
