Stryker ORTHOLOC 3Di Fusion Plate Contains Incorrect Laser Markings
Wright Medical Technology recalls Stryker ORTHOLOC 3Di Fusion Plate MTP Right devices due to incorrect dorsiflexion descriptions laser marked on the parts. 41 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving incorrect labeling on a surgical implant device that could potentially impact surgical accuracy. No illnesses or injuries have been reported, placing this in the risk-of-harm category.
Plain-English summary
Wright Medical Technology, Inc. is recalling the Stryker ORTHOLOC 3Di Fusion Plate MTP Right (Model REF 58A220RT), a device used for bone stabilization and fixation in orthopedic surgery.
The recalled devices contain incorrect dorsiflexion descriptions laser marked on the parts. Incorrect markings on surgical implants could potentially lead to misidentification or improper use during surgical procedures.
A total of 41 units were distributed nationwide in the affected lots. The identified lot number is 1736809 (UDI/DI 00889797101011). This recall has been classified by the FDA as a Class II recall.
The recalled product
- Product
- stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 41
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 (2)
- UDI/DI 00889797101011
- Lot Number 1736809
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 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 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
- HighOrthopedic Bone Fixation Plates Recalled for Incorrect Product Packaging
FDA (Devices) · 2023-03-08
Same hazard · incorrect labeling
See all →- High
- Moderate2022 Nissan Armada and Infiniti QX vehicles with incorrect GAWR label
NHTSA · 2026-07-15
- High
- HighMedtronic Recalls EOPA Arterial Cannula Models for Labeling Errors
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29