WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
FDA Recall #Z-1101-2020 — Class II — December 27, 2019
Product Description
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
Reason for Recall
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.
Recalling Firm
Wright Medical Technology, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
39 devices
Distribution
US
Code Information
Lot Code 1633010
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated