Wright Medical Recalls Valor Screws Due to Sterility Documentation Issues
Wright Medical Technology is recalling 54 units of Valor Screws because adequate documentation confirming sterility was missing.
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, but the source text identifies the issue as a documentation deficiency regarding sterility confirmation rather than a confirmed contamination or reported injury, aligning with the rubric for moderate severity.
Plain-English summary
Wright Medical Technology, Inc. is recalling 54 units of VALOR SCREW 5.0MM X 45MM LEN (Part Number 4151150045). The recall was initiated after the firm discovered a lack of adequate documentation confirming the sterility of these specific products.
The affected products, identified by Lot Number 1547961, were distributed in the United States and internationally to Norway, Italy, Germany, France, South Africa, the UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, and Spain.
Consumers and healthcare providers should stop using these specific units and contact Wright Medical Technology for instructions on return or replacement.
The recalled product
- Product
- VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 54
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 1547961
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 12 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 12 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 · sterility documentation
See all →- ModerateWright Medical Recalls PRO-STIM Injectable Due to Sterility Documentation Issues
FDA (Devices) · 2019-12-04
- ModerateWright Medical Recalls Tibial Stem Components Due to Sterility Documentation Issues
FDA (Devices) · 2019-12-04
- ModerateWright Medical Recalls Swanson Trapezium Implants Due to Sterility Documentation Issues
FDA (Devices) · 2019-12-04
- ModerateWright Medical Recalls Evans Opening Wedge Plates Due to Sterility Documentation
FDA (Devices) · 2019-12-04
- ModerateWright Medical Recalls Dart Fire Headed Screws Due to Sterility Documentation Issues
FDA (Devices) · 2019-12-04
Similar recalls
- HighWright Medical Recalls Evolve Stem Implants Due to Sterility Assurance Issues
FDA (Devices) · 2020-09-30
- ModerateWright Medical VALOR Nail Recall for Missing Compression Screw
FDA (Devices) · 2018-04-25
- HighWright Medical Recalls 3.5mm Claw Plates Due to Incorrect Raw Material
FDA (Devices) · 2014-09-17
- ModerateWright Medical Recalls EVOLVE Modular Radial Head 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 EVOLVE Modular Radial Heads Due to Sizing Errors
FDA (Devices) · 2020-02-12