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
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.
See all 4 products in this recall →Related recalls
Same manufacturer · Wright Medical Technology, Inc.
See all →- HighStryker Infinity Resection Adjustment Block Recall: Missing Locking Screw
FDA (Devices) · 2024-04-10
- HighStryker Infinity Alignment Frame Distal Sub-Assembly Recalled for Manufacturing Defect
FDA (Devices) · 2023-07-12
- HighStryker ORTHOLOC 3Di Fusion Plate Contains Incorrect Laser Markings
FDA (Devices) · 2023-05-03
- HighStryker ORTHOLOC 3Di Fusion Plate Recalled for Incorrect Marked Descriptions
FDA (Devices) · 2023-05-03
- HighBone fixation plates recalled due to product packaging mix-up
FDA (Devices) · 2023-03-08
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02