Product Wiki · Recalls · U.S. FDA — Device Enforcement

WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220 — recall Z-1101-2020

U.S. FDA — Device Enforcement · United States · 2019-12-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1101-2020
Date of alert
2019-12-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Wright Medical Technology, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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