The Recall Desk
ModerateFDA (Devices)·Z-1626-2015·Announced 2015-05-27

Wright Medical Recalls Phalinx Hammertoe Handles Due to Incorrect Laser Etching

Wright Medical Technology is recalling 124 units of Phalinx Hammertoe Handles because the term 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, and the defect is a labeling/etching error without reported injuries, fitting the Moderate severity criteria for minor labeling errors.

Plain-English summary

Wright Medical Technology, Inc. is recalling 124 units of the PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013. The recall is limited to Lot 1344534, which was distributed nationwide.

The recall was initiated because the term DORSAL was laser etched on the incorrect side on some of the angled handles. This is a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.

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: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY
Affected units
124

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 →