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Terminated

WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220

FDA Recall Z-1101-2020 · Posted None

Recalling FirmWright Medical Technology, Inc.
Recall StatusTerminated
Product CodeKWI
Date Initiated2019-12-27
Date Terminated2021-07-23
Product Quantity39 devices

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.

Firm Action

The firm initiated the recall by email and letter on 12/27/2019. The notices requests the following actions: Immediately quarantine all recalled products they have and return all affected product to Wright Medical as soon as possible. If they have further distributed the affected product, we are asking them to notify the applicable parties at once about this recall. They may copy and distribute the notification letter and Wright Medical will work directly with them to collect the recalled items.

Root Cause

Process control

Distribution Pattern

US

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060731EVOLVE MODULAR RADIAL HEADWrightmedicaltechnologyinc · 2006-04-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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