Recalls / —

—#136235

Product

PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY

FDA product code

HWC — Screw, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

Affected lot / code info

Lot 1344534

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Wright Medical Technology, Inc.

Address

1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern

Nationwide Distribution

Timeline

Recall initiated

2015-04-16

Posted by FDA

2015-05-18

Terminated

2018-10-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #136235. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.