Lower riskMedical device recall · FDA · Published August 3, 2022
Wright Medical EVOLVE Proline Stem Recall: Wrong Size in Package
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 EVOLVE Proline Stem Recall: Wrong Size in Package.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60219-wright-medical-evolve-proline-stem-recall-wrong-size-in-package. Based on FDA recall #Z-0006-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0006-2023%22&limit=1).
Wright Medical Technology, Inc. recalled stryker EVOLVE Proline Stem and Wright s EVOLVE Proline Plus Radial Head devices due to labeling mismatches, the FDA said on August 3, 2022. The outer label does not match the device inside the package.
Wright s EVOLVE Proline Plus Radial Head and Repair System
Lot Number 1704255
UDI/DI: (01)008404201856775(11)210831(17)290829
The hazard
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.
Context
GovInfoNow's records show Wright Medical Technology, Inc. has had 20 other recalls since March 14, 2018. Other recent recalls of similar products include Charlotte Claw Screw Recall (August 18, 2026), Stryker Infinity Resection Adjustment Block Recall (March 6, 2024), and Stryker Infinity Alignment Frame Distal Sub-Assembly Recall (June 13, 2023).
How to tell if you have this one
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).
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
Ongoing
Distribution
US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-0005-2023
stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.; UDI/DI: (01)00840420185877(11)210107(17)290105 Lot Number 1704691
16 units
Z-0006-2023
stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.; UDI/DI: (01)008404201856775(11)210831(17)290829 Lot Number 1704255
32 units
Based on the official FDA remedy
What to do — step by step
Check Package Label
Verify the product's size and lot number against the official recall information to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0006-2023 (August 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0006-2023 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.