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

FDA device recall Z-1626-2015 · posted 2015-05-18 · Terminated

Recall details

Recalling firm

Wright Medical Technology, Inc.

Reason for recall

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

Action taken

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 complaints@wmt.com or fax to 901-867-7401. Customers with questions should call 901-451-6144.

Root cause

Process control

Status

Terminated

Product code

HWC

Quantity affected

124 units

Distribution

Nationwide Distribution

Date initiated

2015-04-16

Date posted

2015-05-18

Date terminated

2018-10-18

Location

Memphis, TN