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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 that does not explicitly report injuries or hospitalizations, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Wright Medical Technology, Inc. is recalling 126 units of PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014. The recall involves 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 or exposure to the product might cause temporary or medically reversible adverse health consequences.
Healthcare professionals and patients who have received these specific handles should contact Wright Medical Technology for instructions on how to return or replace the product.
The recalled product
- Product
- PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- 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.
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