FDA recall Z-1102-2020

Wright Medical Technology, Inc. · Class II · device

Product

WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222

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.

Distribution

US

Key facts

Status
Terminated
Initiation date
2019-12-27
Report date
2020-02-12
Termination date
2021-07-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1102-2020