Home / Recalls / Wright Medical Technology, Inc. / Z-0006-2023

Z-0006-2023 Class II Ongoing

Recalled by Wright Medical Technology, Inc. — Memphis, TN

Recall Details

Product Type
Devices
Report Date
October 12, 2022
Initiation Date
August 3, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution.

Code Information

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

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