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Lower risk Medical device recall · FDA · Published December 27, 2019

Wright Medical EVOLVE Proline Head Recall: Wrong Size Product Risk

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.

🇺🇸 FDA recall #Z-1101-2020Medical deviceWright Medical ›
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Recalling firmWright Medical Technology, Inc.1023 Cherry Rd · Memphis, TN 38117-5423
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/66199-wright-medical-evolve-proline-head-recall-wrong-size-product-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66199-wright-medical-evolve-proline-head-recall-wrong-size-product-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1101-2020

Cite this page

“Wright Medical EVOLVE Proline Head Recall: Wrong Size Product Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66199-wright-medical-evolve-proline-head-recall-wrong-size-product-risk. Based on FDA recall #Z-1101-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1101-2020%22&limit=1).

The FDA announced on 2019-12-27 that Wright Medical Technology, Inc. is recalling WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220, Lot Code 1633010 due to incorrect labeling and laser marking that may result in the wrong size product being used. The agency classified this as a Class II recall.

How to tell if you have it

  • Brand: Wright Medical
  • Product: WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
  • Lot Code: 1633010

The hazard

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.

Context

GovInfoNow's records show Wright Medical Technology, Inc. has 20 other recalls on record since 2018-03-14. Other recent recalls include Charlotte Claw Screw Recall (2026-08-18), Stryker Infinity Resection Adjustment Block Recall (2024-03-06), and Stryker Infinity Alignment Frame Distal Sub-Assembly Recall (2023-06-13).

How to tell if you have this one

Check for the product name 'EVOLVE Proline Head', size +2, outer diameter 20mm, and reference number 496H220. The affected units have lot code 1633010.

  • Brand
    Wright Medical
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US
Recall numberProduct, codes & lotsQuantity
Z-1101-2020WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220; Lot Code 163301039 devices
Z-1102-2020WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222; Lot code 163330348 devices
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product name, size, outer diameter, reference number, and lot code to confirm if your item is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Dec 27, 201912. FDA classified it Class II: Feb 6, 202023. Published in FDA’s Enforcement Report: Feb 12, 202034. FDA terminated the recall: Jul 23, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to stop using this product?

No action is required beyond checking the product details. The recall is for labeling issues, not a safety hazard in normal use.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1101-2020 (December 27, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1101-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA