Wright Medical recalls EVOLVE Proline Head Size +2, OD 20mm (REF 496H220) due to incorrect labeling and laser marking. Affected units may have wrong size product.
Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
Wright Medical is recalling a specific size of EVOLVE Proline Head implant due to incorrect labeling and laser marking on the product. This could mean the wrong size product is included in the package, which may cause improper fitting during surgery.
The product may have incorrect labeling and laser markings, which could lead to the wrong size implant being used in surgery. This might cause improper fitting of the implant, but it does not pose a risk of injury during normal use.
Orthopedic surgeons and medical professionals who use the EVOLVE Proline Head implant during surgery. The risk is low as this is a labeling issue rather than a safety hazard in normal use.
Check for the product name 'EVOLVE Proline Head', size +2, outer diameter 20mm, and reference number 496H220. The affected units have lot code 1633010.
Verify the product name, size, outer diameter, reference number, and lot code to confirm if your item is affected.
The recall is due to incorrect labeling and laser markings, which could lead to the wrong size product being used. However, this does not pose a risk of injury during normal use.
Check for the product name 'EVOLVE Proline Head', size +2, outer diameter 20mm, reference number 496H220, and lot code 1633010.
No action is required beyond checking the product details. The recall is for labeling issues, not a safety hazard in normal use.
We’ve drafted a message you can send Wright Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1101-2020 — Wright Medical Wright Medical Hello, I own a Wright Medical that is covered by recall Z-1101-2020 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.
