Wright Medical recalls EVOLVE Proline Stem implants with incorrect sizes in packaging. Affected lots contain mismatched stems 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 size inside. This mismatch could cause improper fitting during surgery if the wrong size is used.
The package labels indicate one size, but the actual implant contains a different size. For example, a package labeled for a 7.5mm +2 stem contains a 9.5mm +4 stem. This mismatch could lead to improper fitting during surgery if the wrong size is used.
Surgical patients who received the recalled EVOLVE Proline Stem implants with mismatched sizes. Surgeons using these specific implants for radial head fractures are most at risk.
Check for the lot number 1704691 on the packaging. The product includes the EVOLVE Proline Stem with size: +2, O: 705mm, REF 496S275.
Verify the size and lot number on the packaging matches the actual implant inside.
The package labels do not match the actual size of the implant inside the package, which could lead to improper fitting during surgery.
The affected lot contains a mismatched size: a package labeled for a 7.5mm +2 stem contains a 9.5mm +4 stem, and vice versa.
Look for the lot number 1704691 on the packaging. The product includes the EVOLVE Proline Stem with size: +2, O: 705mm, 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-0005-2023 — Wright Medical Wright Medical Hello, I own a Wright Medical that is covered by recall Z-0005-2023 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.
