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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a cosmetic or documentation defect (incorrect laser etching) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
Wright Medical Technology, Inc. is recalling 126 units of PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011. The recall was initiated because the term DORSAL was laser etched on the incorrect side on some of the angled handles.
The affected units are identified by Lot 1344534 and were distributed nationwide. This is a prescription-only medical device.
Consumers and healthcare providers should contact Wright Medical Technology, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, 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 →- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- 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 Recalled for Incorrect Marked Descriptions
FDA (Devices) · 2023-05-03
- HighStryker ORTHOLOC 3Di Fusion Plate Contains Incorrect Laser Markings
FDA (Devices) · 2023-05-03
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateWright Medical Recalls EVOLVE Modular Radial Head Due to Sizing Errors
FDA (Devices) · 2020-02-12
- ModerateWright Medical Recalls EVOLVE Modular Radial Heads Due to Sizing Errors
FDA (Devices) · 2020-02-12
- HighWright Medical Recalls Orthopedic Claw Plates Due to Incorrect Raw Material
FDA (Devices) · 2014-09-17
- ModerateWright Medical Recalls Dart Fire Headed Screws Due to Sterility Documentation Issues
FDA (Devices) · 2019-12-04
- ModerateWright Medical Recalls Swanson Finger Joint Implants Due to Sterility Documentation Issues
FDA (Devices) · 2019-12-04
- HighStryker ORTHOLOC 3Di Fusion Plate Recalled for Incorrect Marked Descriptions
FDA (Devices) · 2023-05-03