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.
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. 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
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- 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.
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