Wright Medical Technology, Inc.: 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.

Agency Publication Date: October 4, 2022

Affected Products

Product: 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

Lot Numbers:

Number

Product: 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

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90772

Status: Active

Manufacturer: Wright Medical Technology, Inc.

Manufactured In: United States

Units Affected: 2 products (16 units; 32 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

UDI/DI: (01)00840420185877(11)210107(17)290105 Lot Number 1704691

Lot Numbers:

Number

UDI/DI: (01)008404201856775(11)210831(17)290829 Lot Number 1704255

Lot Numbers:

Number