The Recall Desk
LowFDA (Devices)·Z-1624-2015·Announced 2015-05-27

Wright Medical Recalls Phalinx Hammertoe Handles Due to Incorrect Laser Etching

Wright Medical Technology is recalling 126 units of Phalinx Hammertoe Handles because the term DORSAL was laser etched on the incorrect side.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a cosmetic or documentation defect (incorrect laser etching) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.

Plain-English summary

Wright Medical Technology, Inc. is recalling 126 units of PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011. The recall was initiated because the term DORSAL was laser etched on the incorrect side on some of the angled handles.

The affected units are identified by Lot 1344534 and were distributed nationwide. This is a prescription-only medical device.

Consumers and healthcare providers should contact Wright Medical Technology, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product
PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY
Affected units
126

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 1344534

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Wright Medical Technology, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →