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Terminated

PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY

FDA Recall Z-1626-2015 · Posted 2015-05-18

Recalling FirmWright Medical Technology, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2015-04-16
Date Terminated2018-10-18
Product Quantity124 units

Reason for Recall

The term DORSAL was laser etched on the incorrect side on some of the angled handles.

Firm Action

Wright sent an Urgent Medical Device Recall letter dated April 13, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product, send it back to Wright Medical as soon as possible. Contact Customers Service at 901-867-4575 for return instructions and replacement inventory. Customers were instructed to complete the attached response immediately, confirming their receipt of this notice and the status of any product(s) on had, and return a copy by email to [email protected] or fax to 901-867-7401. Customers with questions should call 901-451-6144.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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