Wright Medical EVOLVE Proline Stem Labeling Error Recall
Wright Medical is recalling EVOLVE Proline Stem devices due to labeling errors where the outer package does not match the device inside. Affected devices are size-mismatched, which could lead to incorrect surgical placement.
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 3/5 (High).
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 with a risk-of-harm scenario (implantable surgical devices with size mismatch that could affect patient outcome), and no reported illnesses or injuries are stated in the source. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Wright Medical Technology, Inc. is recalling certain lots of EVOLVE Proline Stem devices that contain size-mismatched stems. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem. The outer label does not match the device inside the package.
These devices were distributed nationwide. Patients and healthcare providers who have received these devices should verify that the device specifications match the outer label before use. If discrepancies are identified, healthcare providers should contact Wright Medical Technology, Inc. immediately.
The recalled product
- Product
- stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 16
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)
- UDI/DI: (01)00840420185877(11)210107(17)290105 Lot Number 1704691
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 →- 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 · mislabeling
See all →- ModerateOrthofix MINIRAIL External Fixation Devices Incorrectly Labeled
FDA (Devices) · 2026-07-22
- ModerateWise Onion Rings recalled for undeclared food color additives
FDA (Food) · 2026-07-15
- HighBakr Brown Butter Chocolate Chunk Cookie Dough Recalled for Undeclared Soy
FDA (Food) · 2026-07-15
- HighStapes prosthesis pistons carry an incorrect functional length on labeling
FDA (Devices) · 2026-06-10
- HighMedline eye trays contain insulin syringes labeled as tuberculin syringes
FDA (Devices) · 2026-06-03
Similar recalls
- ModerateWright Medical Recalls EVOLVE Modular Radial Heads Due to Sizing Errors
FDA (Devices) · 2020-02-12
- ModerateWright Medical Recalls EVOLVE Modular Radial Head Due to Sizing Errors
FDA (Devices) · 2020-02-12
- HighWright Medical Recalls Evolve Stem Implants Due to Sterility Assurance Issues
FDA (Devices) · 2020-09-30
- HighWright EVOLVE TRIAD Plate Cutter fails sterilization requirements under double-wrap configuration
FDA (Devices) · 2022-07-20
- HighMedtronic Evolut PRO+ System Recalled for Valve Leaflet Damage Risk
FDA (Devices) · 2020-12-16
- HighStryker Latitude EV Humeral Revision Stem Trial with Incorrect Marking
FDA (Devices) · 2025-04-30