The Recall Desk
ModerateFDA (Devices)·Z-1625-2015·Announced 2015-05-27

Wright Medical Recalls Phalinx Hammertoe Handle Due to Incorrect Etching

Wright Medical Technology is recalling 121 units of Phalinx Hammertoe Handles because the word 'DORSAL' was laser-etched on the incorrect side.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect labeling (etching) which could lead to improper surgical orientation, but no injuries or illnesses are reported in the source text.

Plain-English summary

Wright Medical Technology, Inc. is recalling 121 units of the PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012. The recall is due to a manufacturing error where the term DORSAL was laser etched on the incorrect side of some of the angled handles.

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

Healthcare providers and patients should stop using the affected handles and contact Wright Medical Technology for instructions on return or replacement.

The recalled product

Product
PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY
Affected units
121

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 →