Wright Medical Recalls 3.5mm Claw Plates Due to Incorrect Raw Material
Wright Medical Technology is recalling 9 units of CLAW 3.5mm plates because they were manufactured from an incorrect raw material.
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: The recall is classified as FDA Class II, and the hazard involves a structural defect (incorrect raw material) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Wright Medical Technology, Inc. is recalling 9 units of the CLAW 3.5mm Plate Charlotte F&A System, Size 30mm, 2 Hole, Reference 4013-0130. The recall is due to the plates being manufactured from an incorrect raw material.
The affected units are identified by Lot Number 1509955. These orthopedic plates are prescription-only and non-sterile. The distribution pattern includes nationwide distribution in the United States and international distribution to Canada, Australia, Great Britain, Germany, Spain, the Netherlands, and France.
Healthcare providers and patients should contact Wright Medical Technology for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 9
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 Number: 1509955
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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 9 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 · material defect
See all →- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- ModerateParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- HighNexxZr dental zirconia discs may have reduced or missing dentin layer
FDA (Devices) · 2026-06-17
- HighMAC two-lumen central venous kits recalled over incorrectly manufactured adhesive
FDA (Devices) · 2026-04-29
- HighArrowg+ard Blue Plus four-lumen CVC kits recalled over adhesive manufacturing
FDA (Devices) · 2026-04-29